BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 861985 · Received May 22, 2007

    Report

    Report Number
    861985
    Date Received
    May 22, 2007
    Date of Event
    December 19, 2006
    Report Date
    May 22, 2007
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC
    Product Code
    DWC
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    HEATER UNIT WENT INTO UNCONTROLLED HEAT MODE WITH NO ALARM AFTER AN EMERGENCY GENERATOR TEST. CONTROLS WERE UNRESPONSIVE. OPERATOR DISCOVERED THE PROBLEM BEFORE IT AFFECTED THE PATIENT. UNIT RESET. HOSPITAL TESTED UNIT AND FOUND NO PROBLEM. UNIT SENT TO MANUFACTURER TO TEST. THE MANUFACTURER HAS OBSERVED THIS EVENT AT OTHER FACILITIES. THEY RECOMMEND WE IMPLEMENT A PLAN TO INFORM STAFF THAT THIS COULD OCCUR DURING A GENERATOR TEST SO THEY CAN MONITOR AT RISK PATIENTS. THIS MAY BE REASONABLE FOR KNOWN GENERATOR TESTS, HOWEVER IT LEAVES YOU QUITE VULNERABLE. TWO EMAILS TO THE VENDOR HAVE NOT YIELDED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ECMO HEATER DWC CINCINNATI SUB-ZERO PRODUCTS, INC 333W *

    Patients

    Seq Age Sex Outcome Treatment
    1 *