BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE CHROME PALM ANEROID MANOMETER

    MDR report key: 2622855 · Received June 8, 2012

    Report

    Report Number
    MW5025859
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 8, 2012
    Manufacturer
    BRIGGS HEALTH CARE
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFLATION BULB UNEXPECTEDLY FELL OFF SIGNATURE CHROME PALM ANEROID MANOMETER DURING USE. THIS DEVICE WAS WITHOUT EVIDENCE OF DAMAGE PRIOR TO FAILURE. THIS FAILURE DELAYED PROPER ASSESSMENT OF A PATIENT DURING EMERGENCY MEDICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE CHROME PALM ANEROID MANOMETER ANEROID MANOMETER DXQ BRIGGS HEALTH CARE 05-226-060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other