BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150316 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00642
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL DISTRIBUTOR HAS NOT REC'D THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INITIAL REPORT INDICATED THAT THE EVENT WAS REPORTED TO A ZOLL DISTRIBUTOR (DESCRIBE EVENT OR PROBLEM) AND THAT ZOLL DISTRIBUTOR HAS NOT RECEIVED THE PRODUCT IN COMPLAINT (ADDITIONAL NARRATIVES/DATA). THIS INFORMATION IS INCORRECT AND SHOULD INDICATE ZOLL, NOT THE DISTRIBUTOR. IN ADDITION, THE "DISTRIBUTOR" REPORT SOURCE BOX. REPORT SOURCE SHOULD NOT HAVE BEEN CHECKED. THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 05/08/2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THE DISPLAY WAS DAMAGED, THEREBY CONFIRMING THE COMPLAINT. A DEFINITIVE ROOT CAUSE FOR THIS DAMAGE COULD NOT BE DETERMINED BASED ON THE EVALUATION RESULTS. A FUNCTIONAL CHECK WAS PERFORMED TO VERIFY QUANTITY, AMPLITUDE, AND PRESSURE OF COMPRESSIONS AND THE UNIT MET SPECIFICATIONS. MECHANICAL COMPONENTS INCLUDING THE BRAKE, LIFEBAND SWITCH AND SHAFT LOCK WERE ALSO TESTED AND FOUND TO MEET SPECIFICATION. IN SUMMARY, THE REPORTED COMPLAINT OF A DAMAGED DISPLAY WAS CONFIRMED DURING VISUAL INSPECTION OF THE DEVICE, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A ZOLL DISTRIBUTOR THAT THE AUTOPULSE PLATFORM WAS USED ON A PT WHO HAD DROWNED AND THE DISPLAY WAS DEFECTIVE. NO ADVERSE PT SEQUELAE WAS REPORTED. MFR REQUESTED ADD'L INFO ON (B)(4) 2013; HOWEVER, NO FURTHER INFO HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238460 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1