BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 728976 · Received July 14, 2005

    Report

    Report Number
    1821850-2005-00022
    Event Type
    Malfunction
    Date Received
    July 14, 2005
    Date of Event
    June 21, 2005
    Report Date
    July 14, 2005
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF UNIT, FOUND THAT DEVICE HAD BEEN TAMPERED WITH AND ADJUSTED INCORRECTLY. IN ADDITION TO THE ADJUSTMENT MADE, HOSE ROUTINGS FOUND MIS-ROUTED. OBVIOUS TAMPERING OF UNIT NEGATES ANY POSSIBILITY OF DETERMINING ROOT CAUSE. REPORTED AS DEVICE PROBLEM AS PHYSICIAN OPERATING EQUIPMENT REPORTED THAT PROBLEM WITH UNIT DID NOT CAUSE DEATH OF PT. UNIT REPAIRED AND RETURNED TO CUSTOMER. ANALYSIS, RESULTS, RECOMMENDATIONS: ADDITIONAL TEST METHODS USED: DISASSEMBLED AND INSPECT. TEST RESULTS AND OBSERVATIONS SUMMARY: COMPLAINT CONFIRMED. UNIT DID NOT CYCLE UPON RECEIPT. ANALYSIS / ROOT CAUSE: UNIT TAMPERED WITH. VOR DETENT SCREWS ADJUSTED TO THE FULL IN POSITION. FLO-CONTROL AND TURBIN HOSES ATTACHED TO WRONG LOCATIONS CAUSING PNEUMATIC LOGIC PROBLEMS. RECOMMENDED REPAIRS: RELUBE PISTON AND DOME ASSEMBLY RELUBE PISTON BEARING. REPLACE HOSES AS NECESSARY.

    Description of Event or Problem · 1

    DEVICE WAS NOT COMPRESSING OR VENTILATING. THE UNIT HAD NO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN