BIPAP VENTILATOR
Received Mar 12, 1997 · Event occurred Oct 10, 1996
Report 76714 · MDR key 76714
Device
Generic name
Support System
Manufacturer
Respironics, Inc.Model number
ST #332203Catalog number
*
Lot number
*
Product problems
- Measurements, inaccurate
- Device Alarm System
- Defective Alarm
- Low Audible Alarm
- No Audible Alarm
- Alarm, error of warning
- Alarm, failure of warning
- Antenna, failure of
- Computer failure
- Computer hardware error
- Computer Software Problem
- Connection error
- Disconnection
- Erratic or Intermittent Display
- Display or Visual Feedback Problem
- Error or warning message, failure to produce
- False Device Output
- False Reading From Device Non-Compliance
- Interference with monitoring device
- Incorrect Measurement
- Misconnection
- Monitor display alarm, failure of
- Monitor failure
- Radio Signal Problem
- Failure to Transmit Record
- Failure to Sense
- Failure to Read Input Signal
- Telemetry Discrepancy
- Unknown (for use when the device problem is not known)
- Radiofrequency Interference (RFI)
Patient
28 MO
- Cardiopulmonary Arrest
- Asphyxia
- Brain damage
Narrative
Description of Event or Problem
THE PT WAS A 2 1/2 YR OLD GIRL WHO HAD BEEN BORN WITH SEVERE BIRTH DEFECTS INCLUDING A FUSED ESOPHAGUS AND TRACHEA. FOR ABOUT 19 MONTHS BEFORE THE INCIDENT, THE CHILD HAD BEEN A PT AT A CHRONIC REHABILITATION HOSP. DURING THE DAY, THE PT HAD BEEN ON MIST TO HER TRACHEOTOMY TUBE. AT NIGHT, SHE REQUIRED VENTILATION SUPPORT AND WAS CONNECTED TO A VENTILATION SYSTEM AS WELL AS CARDIAC AND RESPIRATORY MONITORING AND ALARM SYSTEMS. ON THE EVENING OF 10/10/96 FOR REASONS THAT HAVE NOT YET BEEN DETERMINED, THE TUBING CONNECTING THE PT TO THE VENTILATION SYSTEM BECAME DISCONNECTED AT THE HEATER UNIT, AND THE PT HAD A CARDIAC ARREST. WHILE NO FINAL CONCLUSIONS CAN BE DRAWN AT THIS TIME, CERTAIN INFO GIVES RISE TO A PRELIMINARY DETERMINATION THAT A DEFECT IN THE VENTILATION SYSTEM AS WELL AS THE RELATED MONITORS AND ALARMS SYSTEMS MAY HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THE MEDICAL STAFF WAS ABLE TO REGAIN THE PT'S HEART RATE, BUT SHE HAD NO SPONTANEOUS RESPIRATIONS. AFTER STABILIZATION, THE PT WAS TRANSFERRED TO THE ICU OF ANOTHER HOSP WHERE IT WAS DETERMINED THAT THE PT HAD SUFFERED SEVERE ANOXIC INJURY. TWO DAYS AFTER THE INCIDENT, THE PT'S PARENTS DECIDED TO WITHDRAW LIFE SUPPORT, AFTER WHICH THE PT DIED.