BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 26 P-WASS 10/04

    MDR report key: 3223774 · Received July 12, 2013

    Report

    Report Number
    0001831750-2013-06288
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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 UNIT WAS REPAIRED FOR THE CUSTOMER. THIS WAS REPORTED IN ERROR. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY STRYKER MEDICAL SCRAPPING THE UNIT AND A NEW UNIT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO DAMAGED LATCHING SPINDLE BRACKET 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 SIDE RAIL COULD NOT REMAIN LATCHED DUE TO DAMAGED LATCHING SPINDLE BRACKET 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
    321770 RENAISSANCE 26 P-WASS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1