BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3173456 · Received May 28, 2013

    Report

    Report Number
    3003793491-2013-00621
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. HOWEVER, THE AUTOPULSE PLATFORM WITH SN (B)(4) WAS RETURNED AND ARCHIVE DATA WAS COLLECTED. ACCORDING TO THE RESULTS FROM ACHIEVE DATA, BATTERY WITH SN (B)(4) WERE USED ON THE DATE OF THE REPORTED COMPLAINT ((B)(6) 2013). A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: 3003793491-2013-00619 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4); 3003793491-2013-00620 FOR AUTOPART NIMH BATTERY WITH SN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE AUTOPULSE PLATFORM WAS STILL COMPRESSING A PT IN THE ER, HEALTHCARE WORKER SHOCKED THE PT, WHICH COMPLETELY DRAINED THE AUTOPULSE NIMH BATTERY. THE BATTERY HAD TO BE REPLACED. IT DID IT AGAIN ON THE BATTERY THAT WAS PUT IN WHEN THE PT WAS SHOCKED AGAIN. CUSTOMER CONCLUDED THAT WHEN A PT IS SHOCKED, THE AUTOPULSE NEEDS TO BE PAUSED SO AS TO NOT DRAIN THE BATTERY. THE PLATFORM RAN FINE OTHER THAN THAT AND WAS GIVING ADEQUATE COMPRESSIONS. THE PT WAS PLACED APPROPRIATELY. NO ADVERSE PT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233344 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT WAS SHOCKED