The investigation into the electrocution of a 12-day-old boy in his hospital bassinet is focusing on the possibility that the cables of his heart monitor were plugged directly into an electrical power source, authorities said Wednesday.
Cook County Medical Examiner Edmund Donoghue Jr. said tests conducted Wednesday by an independent engineering firm in Naperville ruled out any machine malfunction on the breathing and cardiac monitor itself, prompting authorities now to suspect “human error” in the way the infant was attached to the system.
They now suspect that the wires attached to the electrodes on the baby’s chest were mistakenly plugged into a hospital power source rather than into the machine that monitors cardiac and breathing activity, Donoghue said.
The design problem that would permit such a mistake was first detected in 1985 by the U.S. Food and Drug Administration, which issued a nationwide warning after the electrocutions of several babies.
Stratton Vasilakos died Monday in Christ Hospital and Medical Center in Oak Lawn after a nurse switched his cardiac and breathing monitor from a battery source to regular power.
The baby’s body went rigid, he experienced a seizure and medical personnel in the nursery reported smelling something burning, investigators said. His chest bore burn marks where the electrical leads had been connected.
Donoghue has ruled that his death was caused by electrocution with 120 volts of current running through his body for “probably minutes,” he said.
“It appears the machine was used improperly,” said Mark O’Donnell, a Christ Hospital vice president, after tests confirmed that the monitor did not malfunction. O’Donnell also blamed a “design flaw” for contributing to the baby’s death, but he would not specify the nature of the problem.
The hospital staff has been devastated by the baby’s death, according to a variety of sources.
“I’ve never seen the nurses in the nursery so upset about anything in my life,” Donoghue said.
Stratton was born Aug. 11, a full-term, 7-pound, 14-ounce baby boy who was apparently healthy except for a low blood sugar problem, doctors have said.
He was kept in the hospital to be monitored for the hypoglycemia, which can cause problems with breathing, and doctors had expected to send him home before week’s end.
Instead, he was killed when the cables designed to save his life instead delivered a fatal surge of electricity directly to his heart.
The U.S. Food and Drug Administration, which launched its own investigation Wednesday into Stratton’s death, said that breathing and cardiac monitors were blamed for the electrocution deaths of several infants during the 1980s.
The FDA issued a safety alert in 1985 after several cases of “user error or misuse” when cables attached to the monitoring leads on babies’ chests were incorrectly plugged into wall sockets or power extension cords instead of into the monitors, said FDA spokeswoman Sharon Snider.
Such problems were supposed to have been corrected by design changes that made the plugs on the cables attached to patients incompatible with power source sockets.
The monitor used by Christ Hospital on the baby was manufactured in 1992 and was shipped with the newly designed safety cables, according to John Skule, vice president of corporate affairs for Corometrics Medical Systems, the manufacturer of the monitor. Hospital officials said the unit was purchased in 1990.
However, Donoghue said that his investigation has determined that the cable used at the hospital did not have the safety feature. He said he was not certain who manufactured the suspect cable, and he cautioned area hospitals to check their monitoring equipment for “incompatability protection so that this wouldn’t happen again.”
According to O’Donnell, the newborn unit where the infant died has “40 to 50” apnea monitors. About 7 are the same brand as the one tested in the Vasilakos’ case, and O’Donnell said he did not know if leads from other manufacturers’ devices are routinely mixed or matched on the unit.
It was not clear late Wednesday whether the FDA requires manufacturers to incorporate the safety feature on leads.
An FDA inspector was present Wednesday as Donoghue, representatives from Christ Hospital and the monitor manufacturer, gathered at Packer Engineering in Naperville where the Neo Track Monitor Model 502 was put through three hours of rigorous testing.
Also present was George Gatses, an attorney representing the Vasilakos family, who borrowed a camera from a news photographer to document elements of the testing for a lawsuit he is planning to file on behalf of the family.
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Gatses said afterward that the tests indicated that the machine had a “clean bill of health,” but added, “I still foresee a lawsuit with the hospital and any other parties involved.”
Because the monitor was initially suspected of having malfunctioned, several area hospitals, including Victory Memorial in Waukegan and Highland Park Hospital, have suspended use of that model as “precautionary measures,” according to hospital spokesmen.
In addition, the electrocution also caused concern among parents using home monitors on infants.
As many as 40,000 babies born every year are sent home with monitors to gauge respiratory or heart functions, estimates Dr. Alfred Steinschneider, president of the American Sudden Infant Death Syndrome Institute, an Atlanta-based national program involved in SIDS research and education.
Monitors are most commonly prescribed for infants with prolonged apnea-a condition in which the baby stops breathing for periods of more than 20 seconds, experts say. The monitors sound an alarm when the baby stops breathing.
The FDA issued another safety alert regarding home monitors in 1990 after several reports of infants dying without the monitor’s alarm being triggered, according to FDA spokeswoman Snider.
This alert mainly cautioned parents to refrain from making monitor adjustments in an effort to decrease false alarms because such adjustments can disable the machines.
Hours before the experts gathered in Naperville at the testing firm, Stratton Vasilakos’ parents were at a local mortuary making funeral arrangements.
The baby will be buried Thursday at Evergreen Cemetery in Evergreen Park after a short private afternoon visitation and service at the V. Hills Funeral Home, 10201 S. Robert Rd., Palos Hills.