BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CRITICAL CARE BED

    MDR report key: 2864696 · Received November 9, 2012

    Report

    Report Number
    1831750-2012-11718
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY SIGMA WITH THE SPECTRUM PUMP THAT WAS ATTACHED TO THE DEVICE AT THE TIME OF THE EVENT (S/N (B)(4)) AND FOUND THE PUMP TO HAVE AN INTERMITTENT BATTERY CONNECTION DUE TO A FAILED WIRELESS MODULE. THIS MAY CAUSE AN IMPROPER SHUTDOWN WHILE OPERATING ON BATTERY POWER ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS NOT OPERATING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1