BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 2253568 · Received August 10, 2011

    Report

    Report Number
    1831750-2011-08075
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: CALF SUPPORT. CONCLUSION: THE CUSTOMER HAS BEEN SENT REPLACEMENT PARTS AND THE BED WILL BE REPAIRED BY STRYKER FIELD SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER IS ALLEGING THAT ALL OF THEIR CALF SUPPORTS ON THE MATERNITY BED ARE LOOSE AND DO NOT SUPPORT PATIENT WEIGHT. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD304 MATERNITY BED LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1