FDA Adverse Event Death Summary report: N

N/A

MDR report key: 80 · Received February 25, 1992

Report

Report Number
80
Event Type
Death
Date Received
February 25, 1992
Date of Event
December 30, 1991
Report Date
February 11, 1992
Manufacturer
INSTRUMENTATION INDUSTRIES, INC
Product Code
BYE
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON DECEMBER 30, 19991 AT ABOUT 6:20 PM A STAFF RN WAS PASSING MEDICATIONS ON THE MEDICARE HALL, CAMBRIDGE WING. SHE HEARD A VENTILATOR ALARM GO OFF AND WENT TO INVESTIGATE. SHE FOUND THE VENTILATOR'S LOW PRESSURE ALARM WAS ACTIVATED AND SHE FOUND THE TUBING WAS DISCONNECTED AT THE PEEP VALVE. SHE RECONNECTED THE TUBING AT THE PEEP VALVE HOWEVER THE ALAARM CONTINUED TO SOUND. SHE NEXT CHECKED TO BE SURE THERE WAS NO INTERRUPTION OF THE OXYGEN SUPPLY. THE RESIDENT APPEARED TO BE BREATHING AT THIS TIME SO THE NURSE LEFT TO PAGE ANOTHER NURSE FOR ASSISTANCE. WITHIN APPAROXIMATELY ONE MINUTE OF THE TIME SHE LEFT TO GET ASSISTANCE, SHE AND TWO OTHER NURSES RETURNED TO THE ROOM. AT THIS TIME THE RESIDENT WAS NOIN RESPONSIVE AND DID NOT HAVE A PULSE. CPR WAS NOT INITIATED BECAUSE THE RESIDENT WAS A NO CODE. THE DOCTOR AND FAMILY WERE NOTIFIED.AN EXAMINATION OF THE PEEP VALVE AND QUESTIONING OF THE STAFF REVEALED THE FOLLOWING:1. THE PEEP VALVE MAY HAVE BEEN RECONNECTED INCORRECTLY BY THE NURSE.2. THERE WAS A MISSING DIAPHRAGM THAT SHOULD HAVE BEEN IN THE PEEP VALVE. PROBABLY LOST WHILE NURSES WERE WORKING WITH THE EQUIPMENT DURING THE INCIDENT OR DURING EXAMINATION OF THE EQUIPMENT AT A LATER TIME. THIS IS UNKNOWN.3. IT IS UNCLEAR WHETHER THE RESIDENT DIED AS A RESULT OF THE PEEP VALVE BEING INCORRECTLY CONNECTED OR FROM OTHER RELATED CAUSES. IF RESIDENT DIED FROM CARDIAC ARREST OR OTHER CAUSES THIS WOULD BE CONSISTENT WITH HIS MEDICAL HISTORYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, NONE OR UNKNOWN, MISAPPLICATION OF DEVICE, VALVE - SAFETY. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 N/A ADJUSTABLE MAGNETIC PEEP VALVE BYE INSTRUMENTATION INDUSTRIES, INC BE142

Patients

Seq Age Sex Outcome Treatment
1 75 YR Death