BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 26 P-WASS 10/04

    MDR report key: 3021560 · Received March 26, 2013

    Report

    Report Number
    0001831750-2013-02510
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, IT WAS REPORTED THAT THE DEVICE WAS REPAIRED. THE CUSTOMER WAS SENT A NEW LITTER AS A RESULT OF THE WARRANY AND REPAIRED THE UNIT THEMSELVES. ADDITIONALLY, AS A RESULT OF THE WELD DAMAGE SHARP EDGES WERE EXCESSIBLE, WHICH WAS ALSO NOT REPORTED IN THE PREVIOUS MDR ISSUED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE LATCHING SPINDLE WELD BROKE ON THE LITTER. 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 LATCHING SPINDLE WELD BROKE ON THE LITTER. 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
    123265 RENAISSANCE 26 P-WASS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1