BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) B900

    MDR report key: 3823091 · Received January 20, 2014

    Report

    Report Number
    3007538326-2014-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 16, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BED WAS INSPECTED BY PRIMUS MEDICAL ON (B)(6) 2014. THE INSPECTION DETERMINED THAT THE BRACKET WHERE THE HEAD HIGH-LOW ACTUATOR MOUNTS ONTO THE BACKBONE OF THE BED FRAME BROKE OFF. A NEW BED FRAME WAS SHIPPED TO THE FACILITY ON (B)(6) 2014. THIS PROBLEM HAS BEEN ASSIGNED CAPA (B)(4), AND A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND SAID THAT THEY HAD A BED WITH A BROKEN WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46642 PRIME CARE (R) B900 FNL PRIMUS MEDICAL LLC PCB900

    Patients

    Seq Age Sex Outcome Treatment
    1