BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3182255 · Received June 21, 2013

    Report

    Report Number
    3003793491-2013-00695
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 7, 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

    THE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED. THE CLUTCH PLATE WAS FOUND DEFECTIVE AND IT WAS REPLACED. THE PLATFORM PASSED FINAL TEST. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR CUSTOMER'S REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON 06/24/2013 REGARDING THE DATE OF EVENT. SERVICE TECHNICIAN DID NOT KNOW THE EXACT DATE OF EVENT BUT STATED THAT EVENT PROBABLY OCCURRED AROUND (B)(6) 2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MOTOR OF THE AUTOPULSE PLATFORM IS BLOCKED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: THE AUTOPULSE PLATFORM WAS SENT WITH A PATIENT TO THE HOSPITAL. CUSTOMER FOUND THAT THE PLATFORM'S MOTOR IS DEFECTIVE. 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
    281853 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1