BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3170780 · Received May 22, 2013

    Report

    Report Number
    3003793491-2013-00586
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 27, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RECEIVED AND INVESTIGATED BY A ZOLL DISTRIBUTOR. INVESTIGATION RESULTS AS FOLLOWS: THE SHAFT LOCK WAS WORN OUT (LESS THAN 1.5 MM), VOLTAGE OF THE BATTERY WAS LOW (UNDER 2.9V), ONE OF THE HEAD RESTRAINT HAD CRACKED. ARCHIVE DATA WAS COLLECTED AND REVIEWED. THE REPORTED ISSUE OF UA 7 AND 44 APPEARING ON THE SCREEN OF THE PLATFORM WAS CONFIRMED. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO ZOLL DISTRIBUTOR THAT THE AUTOPULSE PLATFORM DID NOT WORK CORRECTLY EVEN THOUGH THE BATTERY WAS FULLY CHARGED. MANUFACTURER REQUESTED ADDITIONAL INFORMATION ON (B)(4) 2013, CUSTOMER PROVIDED THE FOLLOWING INFORMATION ON (B)(6) 2013: THE INCIDENT OCCURRED WHILE THE AUTOPULSE WAS BEING USED ON A PATIENT. THE DEVICE SUDDENLY STOPPED COMPRESSION. USER ADVISORY (UA) 44, 1 AND 7 DISPLAYED ON THE SCREEN OF THE PLATFORM. A NEW BATTERY WAS USED AND THE REPORTED PROBLEM DID NOT RECUR. MANUAL CPR WAS ADMINISTERED TO THE PATIENT. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227382 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR