BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3182251 · Received June 21, 2013

    Report

    Report Number
    3003793491-2013-00694
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON 05/30/2013 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR RETURNED AUTOPULSE PLATFORM IN COMPLAINT AS FOLLOWS: EXTERNAL VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE SHORT BLACK COVER WAS CRACKED/SPLIT. FURTHER INTERNAL VISUAL INSPECTION REVEALED NO DAMAGES. FUNCTIONAL TESTING WAS PERFORMED WITH PASSING RESULTS. THE CUSTOMER'S REPORTED COMPLAINT OF UA07 ERROR MESSAGE WAS VERIFIED. BOTH OF THE LOAD CELLS WERE FOUND TO BE DEFECTIVE AND WERE REPLACED. THE UA07 MESSAGE WAS CLEARED. INVESTIGATION ALSO REVEALED A UA27 (SPOOL SHAFT TURNING TOO FAST DURING COMPRESSION) ERROR MESSAGE. A PROBABLE CAUSE FOR THE UA27 ERROR MESSAGE MAY BE DUE TO A BAD ENCODER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE ENCODER WAS REPLACED AND THE FAULT WAS CLEARED. THE PLATFORM PASSED FINAL TEST. BASED ON THE EVALUATION RESULTS, A PROBABLE ROOT CAUSE FOR THE CUSTOMER'S REPORTED COMPLAINT OF UA07 ERROR MESSAGE MAY BE DUE TO THE DEFECTIVE LOAD CELLS; HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE DEFECTIVE LOAD CELLS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED ERROR MESSAGE 07 - DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION PROVIDED.THE DATE OF EVENT WAS NOT PROVIDED BY THE CUSTOMER. MANUFACTURER HAS REQUESTED THIS INFORMATION FROM THE CUSTOMER BUT HAS NOT RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282430 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1