BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2901969 · Received November 8, 2012

    Report

    Report Number
    3003793491-2012-00166
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO THE MANUFACTURER DID NOT INDICATE A POTENTIAL SAFETY ISSUE. THE AUTOPULSE (S/N (B)(4)) DEVICE WAS RETURNED ON 03/22/2012 TO ZOLL CIRCULATION AND ANALYZED. IT WAS OBSERVED THAT THERE WAS NO VISIBLE DAMAGE TO THE BOARD. THE ARCHIVE DATA EXHIBITED NUMEROUS USER ADVISORY MESSAGES OF "UA13"(BATTERY FAULT DETECT(REPLACE BATTERY). THE ARCHIVE DATA ALSO INDICATED THAT THE FOLLOWING BATTERIES WITH SERIAL NUMBERS ((B)(4)) WERE USED WITH THIS DEVICE. THESE BATTERIES HAD LOW VOLTAGES AND WERE USED DURING COMPRESSIONS, WITH ONLY A FEW TEST CYCLES ON THEM. NO VISIBLE DAMAGE TO THE BOARD WAS OBSERVED AND BOARD PASSED FUNCTIONAL TEST. UNABLE TO REPRODUCE THE CUSTOMER COMPLAINT. THE DEVICE WAS RAN WITH ONE OF OUR TEST BATTERIES FOR 30 MINUTES WITH NO PROBLEMS. ALSO PLACED M-SERIES AND E-SERIES DEFIBRILLATORS NEXT TO THE AUTOPULSE AND PERFORMED 120J, 150J AND 200J MULTIPLE TIMES. CHARGING AND DISCHARGING THE DEFIBRILLATOR HAD NO AFFECT TO THE AUTOPULSE SYSTEM OR THE AUTOPULSE BATTERY THAT WAS USED DURING COMPRESSIONS. ALSO USED THE SAME BATTERY TO RUN THE LRTF(LARGE RESUSCITATION TEST FIXTURE) FOR 5 MINUTES OF COMPRESSIONS, NO PROBLEMS FOUND TO THE BOARD OR THE BATTERY. PROBABLE CAUSE FOR THE REPORTED COMPLAINT AS INDICATED IN THE ARCHIVE DATA IS DUE TO USING LOW VOLTAGE BATTERIES (BATTERIES S/N#: (B)(4)) AND IMPROPER BATTERY MAINTENANCE. BATTERIES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CARE, THE AUTOPULSE RESUSCITATION SYSTEM WAS USED IN CONJUNCTION WITH THE DEFIBRILLATOR INTERFACE. THE SYSTEM WORKED FINE UNTIL THE THIRD SHOCK WAS DELIVERED TO THE PATIENT; 120, 150 AND 200 JOULES WERE USED, AT WHICH POINT THE AUTOPULSE SYSTEM WOULD NOT RUN AND THE THREE BATTERIES WERE READING LOW. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other