BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP-100

    MDR report key: 28483 · Received December 4, 1995

    Report

    Report Number
    MW1007837
    Event Type
    Injury
    Date Received
    December 4, 1995
    Date of Event
    January 1, 1994
    Report Date
    November 24, 1995
    Manufacturer
    LIFECARE SERVICES, INC.
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LEAKS IN THE MASK ARE EXCESSIVE AND IT HAS STARTED TO AFFECT RPTR'S SLEEP. A CO THERAPIST MADE RPTR A CUSTOM MASK. IT DIDN'T WORK. A MONTH LATER CO SENT ANOTHER THERAPIST TO MAKE ANOTHER CUSTOM MASK AND IT DIDN'T WORK. FINALLY CO DELIVERED A CIRCUIT MASK AS THE SOLUTION TO RPTR'S COMPLAINT. IT APPEARS THAT CO DOES NOT WANT TO MODIFY THE EXISTING MASK DESIGN OR INCORPORATE THE SUGGESTIONS THAT RPTR HAS MADE BECAUSE THE FDA WILL NOT APPROVE IT. CO HAS TRIED UNSUCCESSFULLY TO MAKE TWO CUSTOM MASKS THAT DO NOT REQUIRE FDA APPROVAL. ELASTIC HARNESS RUBBER BREAKS DOWN. SWIVEL LEAKS. BOTTOM OF MASK LEAKS. MUFFLER HOLE BAFFLE, HAS BLACK PARTICLES. IT SEEMS EVERY ITEM RPTR RECEIVES VARIES ONE FROM ANOTHER. THE SEALS SPLIT AT THE BRIDGE OF THE NOSE. RPTR HAS HAD TO MODIFY THE MASK TO CONTAIN THE AIR LEAKS BETWEEN THE MASK AND THE FACE SO THAT IT WORKS FOR ITS INTENDED PURPOSE. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP-100 CONTINUOUS POSITIVE AIRWAY PRESSURE MASK BYE LIFECARE SERVICES, INC. CPAP-100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R