BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRICOOL

    MDR report key: 59093 · Received December 19, 1996

    Report

    Report Number
    MW1010484
    Event Type
    Malfunction
    Date Received
    December 19, 1996
    Date of Event
    October 7, 1996
    Report Date
    October 7, 1996
    Manufacturer
    SEABROOK MEDICAL SYSTEMS, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MFR'S RESPONSE RECEIVED ON 5/9/97: UPON RECEIVING THE MEDWATCH FROM THE ATTORNEY, CO CONTACTED HER OFFICE IN JANUARY. SHE DID NOT RESPOND TO REQUEST TO RETURN ELECTRI-COOL UNIT. THE UNIT WAS NEVER RETURNED TO PT CARE DIVISION FOR EVALUATION. HERE AT ZIMMER PATIENT CARE DIVISION, ALL ELECTRI-COOL THERAPY MACHINES HAVE ESTABLISHED UL SPECIFIED ELECTRICAL SAFETY TESTS PERFORMED ON THEM PRIOR TO THE UNITS BEING RELEASED TO FINISHED GOODS. THESE SAFETY TESTS ARE ALSO CONDUCTED ON UNITS IN FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRICOOL ICE COMPRESSION DEVICE ILO SEABROOK MEDICAL SYSTEMS, INC. SMS-6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other