BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT RESCUSITATION BAG

    MDR report key: 9067 · Received July 29, 1994

    Report

    Report Number
    9067
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    April 8, 1994
    Report Date
    April 20, 1994
    Manufacturer
    MERCURY MEDICAL
    Product Code
    LYM
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TWO DAY OLD INFANT BEING MANUALLY RESCSUSITATED DURING CIRCUIT CHANGE OUT OF VENTILATOR. RESPIRATORY THERAPIST NOTICED THAT THE BAG WAS MAL-FUNCTIONING. THE POP OFF SAFETY VALVE WAS INSERTED AT AN ANGLE AND WAS NOT FUNCTIONING.DEVICE 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.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, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING, VALVE - RELIEF. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT RESCUSITATION BAG CPR BAG LYM MERCURY MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other