BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) B900

    MDR report key: 3925289 · Received June 23, 2014

    Report

    Report Number
    3007538326-2014-00053
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BED FRAME HAS NOT BEEN INSPECTED YET DUE TO THE BED FRAME NOT BEING RETURNED YET. THE LOCATION OF WHERE THE ACTUATOR BROKE IS UNKNOWN AT THIS TIME. 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 EMAILED SAYING THEY HAD A BED WITH A BROKEN WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364917 PRIME CARE (R) B900 FNL PRIMUS MEDICAL LLC PCB900

    Patients

    Seq Age Sex Outcome Treatment
    1