FDA Adverse Event Death Summary report: N

COMPANION - VOLUME VENTILATOR

MDR report key: 9761 · Received September 22, 1993

Report

Report Number
9761
Event Type
Death
Date Received
September 22, 1993
Date of Event
June 19, 1993
Report Date
June 22, 1993
Manufacturer
PURITAN BENNETT
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

RESIDENT WAS ADMITTED APRIL 28, 1993, WITH THE VENTILATOR IN USE. ON THE NIGHT OF JUNE 19, 1993, AT APPROXIMATELY 8:10 P.M., THE NURSE, AN LPN, WAS CALLED INTO THE RESIDENT'S ROOM TO ASSIST WITH CARE OF HIS ROOMMATE. AS SHE FINISHED POSITIONING THE ROOMMATE, SHE LOOKED TO THE RESIDENT'S BED. SHE NOTICED HE WAS CYANOTIC, UNRESPONSIVE, EYES FIXED AND HIS INNER CANNULA AND VENTILATOR CIRCUITS WERE DRAPED ACROSS HIS BED RAIL. SHE IMMEDIATELY SOUGHT HELP. ANOTHER LPN ASSISTED AND STARTED TO BAG THE RESIDENT. THE FIRST NURSE THEN WENT FOR ADDITIONAL EQUIPMENT AND NOTIFIED THE CHARGE NURSE, AN RN.THE RESIDENT'S BLOOD PRESSURE WAS 96/27, PULSE 42 ON IVAC AND 02 SATURATION WAS 23 ON OXIMETER. NONE OF THE THREE NURSES COULD HEAR HEART SOUNDS AND COULD NOT PALPATE A PULSE ANYWHERE ON THE RESIDENT. THEY CONTINUED TO BAG THE RESIDENT FOR APPROXIMATELY 15 MINUTES WITH NO POSITIVE CHANGE IN HIS CONDITION. AT 8:35 P.M., A DR., PULMONOLOGIST AND MEDICAL DIRECTOR OF THE SPECIAL CARE UNIT, WAS NOTIFIED THAT THE RESIDENT'S LIFE SIGNS WERE NEGATIVE.DUE TO THE RESIDENT'S SEVERE RESPIRATORY DIFFICULTY HE HAD A MEDICAL DIRECTIVE STATUS OF NO CODE, AND FULL CPR WAS NOT INITIATED. USUALLY HE REQUIRED SUCTIONING THREE TIMES PER SHIFT, PRODUCED MOSTLY YELLOW OR YELLOW/GREEN MUCUS WHICH WAS MODERATELY THICK. VERY BRIEFLY, THE RESIDENT HAD A HISTORY OF REPEATEDLY REMOVING HIS INNER CANNULA AND DISSEMBLING HIS VENTILATOR CIRCUITS. HE HAD RECENTLY BEEN SEEN BY A PSYCHIATRIST. AMONG OTHER PRESCRIBED MEDICATIONS, HE HAS RECEIVED THE FOLLOWING: VALIUM, HALDOL, MELLARIL AND TRAZADONE.THERE WERE NO KNOWN RELEVANT ENVIRONMENTAL CONDITIONS, AND THERE ARE NO PATIENT ANALYSIS RESULTS.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMPANION - VOLUME VENTILATOR N/A PURITAN BENNETT 2801 N/A

Patients

Seq Age Sex Outcome Treatment
1 68 YR Death