BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BED

    MDR report key: 1941158 · Received December 8, 2010

    Report

    Report Number
    1831750-2010-04606
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE R/H HEAD END SIDE RAIL WILL NOT LOCK IN MID OR UP POSITION. DISASSEMBLED SIDE RAIL AND FOUND RETAINING CLIP ON SPRING PLUNGER CAME OFF PREVENTING LATCH PLATE TO ENGAGE INTO LOCKING POSITION. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE 3 MED/SURG BED A/C POWERED HOSPITAL BED FPO STRYKER CORP., MEDICAL DIVISION 3002S3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK