BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUMPER

    MDR report key: 1017305 · Received March 20, 2008

    Report

    Report Number
    1821850-2008-00002
    Event Type
    Death
    Date Received
    March 20, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 20, 2008
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT AND THE INCIDENT WERE EVALUATED BY OUR DISTRIBUTOR. THE CONCLUSION WAS THAT THE DEVICE WAS DAMAGED DUE TO IMPROPER USE AND HANDLING OF THE PT. THE THUMPER WAS BEING USED TO PERFORM CPR WITHOUT THE PT BEING PROPERLY RESTRAINED. NO BACKBOARD WAS BEING USED CONTRARY TO OPERATING INSTRUCTIONS. AFTER 10 MINUTES THE PT FELL OUT OF THE BED AND THEN THE THUMPER FELL TO THE FLOOR BREAKING OFF THE OXYGEN INPUT CONNECTOR. IT WAS THE OPINION OF THE HEAD NURSE THAT THE INCIDENT DID NOT CONTRIBUTE TO THE DEATH OF THE PT. MANUAL CPR WAS CONTINUED. DISTRIBUTOR WAS DIRECTED TO RE-TRAIN THE USER IN PROPER TECHNIQUE FOR USE OF THE THUMPER AND PROVIDE PROOF THAT THE TRAINING HAS BEEN COMPLETED. THE UNIT WAS REPAIRED IN TAIWAN AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL 1007 THUMPER WAS BEING USED ON A PT IN A HOSPITAL SETTING WHEN THE PT FELL OUT OF THE BED. THE THUMPER ALSO FELL FROM THE BED RESULTING IN A BROKEN OXYGEN CONNECTOR. THE PT WAS NOT REVIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR