BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) B900

    MDR report key: 3881756 · Received May 27, 2014

    Report

    Report Number
    3007538326-2014-00044
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 27, 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 UNK AT THIS TIME. A NEW BED FRAME WAS SHIPPED OUT TO THE CUSTOMER ON (B)(6) 2014. THIS PROBLEM HAS BEEN ASSIGNED CAPA (B)(4), AND A FOLLOW-UP 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
    310869 PRIME CARE (R) B900 FNL PRIMUS MEDICAL LLC PCB900

    Patients

    Seq Age Sex Outcome Treatment
    1