BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CRITICAL CARE BED

    MDR report key: 2914278 · Received December 6, 2012

    Report

    Report Number
    1831750-2012-12317
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY ACCOUNT PERSONNEL. (B)(4): OBJECT IN BRAKE SYSTEM. CONCLUSION CODE: OBJECT REMOVED BY ACCOUNT; BRAKES FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM CRITICAL CARE BED AC POWERED HOSPITAL BED FNL STRYKER MEDICAL 2040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1