BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 3746081 · Received April 11, 2014

    Report

    Report Number
    0001831750-2014-02879
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE ALLEGED PRODUCT DEFECT REPORTED DID NOT CONTRIBUTE TO THE REPORTED INJURY. ALL SECONDARY SUPPORT FUNCTIONS WERE WORKING CORRECTLY. HOWEVER, A CELL AT THE FOOT SECTION OF BED WAS NOT HOLDING AIR PROPERLY SO THIS ASSEMBLY WAS REPLACED. THE ISSUE REGARDING SAGGING IS A NON-REPORTABLE. THIS WILL RESULT IN AN ANNOYANCE ONLY ISSUE. PATIENT WOULD BE SUPPORTED BY SECONDARY CELLS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT ALLEGEDLY THE PATIENT HAD SKIN BREAK DOWN. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220615 XPRT MATTRESS W/O PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1