BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT

    MDR report key: 3122037 · Received May 14, 2013

    Report

    Report Number
    MW5030233
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPAT "CHECK WOUND SUCTION PATHWAY." MACHINE KEPT ALARMING. COMPLETELY CHANGED OUT ORTHOPAT MACHINE AND SET UP AND THEN WORKING FINE. THE ORTHOPAT DRAIN NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213510 ORTHOPAT CAC HAEMONETICS CORP. REF # OPT-P-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR