BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEGUARD RESUSCITATION BAG

    MDR report key: 1115 · Received August 18, 1992

    Report

    Report Number
    1115
    Event Type
    Death
    Date Received
    August 18, 1992
    Date of Event
    June 25, 1992
    Report Date
    July 1, 1992
    Manufacturer
    UNKNOWN
    Product Code
    BTC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BAG WAS NOT MECHANICALLY SOUND. 02 TUBE DISCONNECTED SELF FROM END OF BAG AT COMPLETION OF RESUSCITATION. IS SUPPOSED TO BE GLUED IN PLACEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: MANUFACTURING, MECHANICAL PROBLEM, NONE OR UNKNOWN, OTHER, OTHER. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEGUARD RESUSCITATION BAG AMBUBAG BTC UNKNOWN P/N 42021-0 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death