The Food and Drug Administration has found that a faulty incubator, blamed in the death of an 8-day-old baby boy at the Washington Hospital Center last month, had one safety control that periodically malfunctioned and another that was broken.
FDA spokesman Bill Rados said the agency's preliminary findings showed that the incubator's temperature regulator malfunctioned intermittently and that a safety themostat designed to shut off the incubator and sound an alarm if the temperature reached 103 degrees was broken.
Officials at the Washington Hospital Center, in a prepared statement, agreed that these conditions "existed at the time" of the FDA examination, but declined further comment.
FDA investigators examined the incubator, which apparently had not been used since the baby's death on June 21, in the hospital's engineering department on July 13 and 17, according to Rados. According to hospital records, the incubator was removed from the baby ward and brought to engineering on June 22, Rados said.
Rados said the FDA is continuing its investigation to determine if there are any design defects in the incubators used at the hospital, but based on the initial review, "there is no reason to believe that properly maintained and monitored incubators of these make and model would not be safe to use."
The D.C. Medical Examiner's Office ruled that the baby, Taman Jackson, died from massive pulmonary bleeding, which began when the incubator's temperature was elevated above what it should have been, casuing the baby's temperature to rise also. As the baby's temperature rose, causing a condition similar to heat stroke, massive bleeding occurred in his lungs.
Once discovered in the overheated incubator, the baby was taken out, resuscitated and kept alive for 18 hours before dying the morning of June 21. The parents had brought the baby to the hospital two days earlier for treatment of jaundice, a buildup of bile from the liver that often occurs in newborns and is usually corrected with photo therapy treatments, exposing the baby's sking to light.
A spokesman for Narco Scientific Air Shields, Inc., of Hatboro, Pa., which manufactured the malfunctioning incubator, said the company would have no comment on the FDA's finding because the firm has not yet conducted its own independent study of the incubator. He said the incubator, a square metal cabinet with plastic hood and small foam-rubber mattress, was equipped with an alarm that emitted a continuous whistling sound when the temperature inside the incubator reached 103 degrees.
The spokesman, Frank Vitale, said the company, which had supplied most of the hospital's 20 incubators, has no service agreement with the hospital to maintain the incubators. The company does have service agreements with other hospitals.
In the wake of the baby's death, the Hospital Center suspended "some" of the nurses who had worked in the ward where the baby was treated. Hospital spokeswoman Jane Snyder would not comment on the status of the suspensions or the reasons behind them.