BEUDAMED
    FDA Adverse Event Other Summary report: N

    THUMPER

    MDR report key: 236092 · Received August 13, 1999

    Report

    Report Number
    1821850-1999-00005
    Event Type
    Other
    Date Received
    August 13, 1999
    Date of Event
    July 3, 1999
    Report Date
    August 13, 1999
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER CLAIMED THAT THE DEVICE COMPRESSED DEEPER THAN IT WAS SET. IE CHEST COMPRESSIONS WERE SET TO 4 CM BUT A 6-7 CM COMPRESSION WAS DELIVERED. IT WAS INITIALLY REPORTED THAT PT'S RIB WAS BROKEN, BUT THE DR MAKING THE REPORT WOULD NOT CONFIRM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *