BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3003718 · Received February 11, 2013

    Report

    Report Number
    3003793491-2013-00322
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 MINS INTO THE CODE, THE AUTOPULSE RESUSCITATION SYSTEM SHUT OFF AND DISPLAYED REPLACE BATTERY. BATTERY WAS REPLACED, BUT AFTER APPROX 5 MINS, THE AUTOPULSE SHUT OFF INDICATING THAT PT ALIGNMENT WAS OFF. CUSTOMER INDICATING THAT DUE TO THE PT'S SHAPE AND EVEN THOUGH THE CHEST STRAPS WERE TIGHTENED, THE WEIGHT SENSOR PERCEIVED THE PT TO BE OFF THE PLATFORM. THE DISPLAY ALSO INDICATED USER ADVISORY 12 (LIFEBAND NOT PRESENT). NO ADVERSE EVENT REPORTED. AUTOPULSE PLATFORM, MFR REPORT# 3003793491-2013-00319, BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00320, BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00321, BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59548 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other