BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 P-WASHOBS10/04

    MDR report key: 3102802 · Received May 9, 2013

    Report

    Report Number
    0001831750-2013-04205
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALSO FOUND DURING THE INVESTIGATION THAT THE BROKEN WELD AT THE PATIENT RIGHT LATCHING SPINDLE HAD EXPOSED SHARP EDGES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE PATIENT RIGHT SIDE RAIL WOULD NOT LATCH DUE TO A BROKEN WELD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE PATIENT RIGHT SIDE RAIL WOULD NOT LATCH DUE TO A BROKEN WELD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203756 RENAISSANCE 29 P-WASHOBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1