BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4090771 · Received September 15, 2014

    Report

    Report Number
    3010617000-2014-00466
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE PLATFORM IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 09/08/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THE MOTOR COVER TO BE DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE CUSTOMER'S REPORTED COMPLAINTS OF A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) AND THAT THE "HOME" POSITION WAS OFF BY 180 DEGREES. THE RETURNED PLATFORM UNDERWENT AND PASSED INITIAL FUNCTIONAL TESTING. THE SYSTEM WAS TURNED ON/OFF WITH NO PROBLEMS AND RAN FOR 15 MINUTES USING A LARGE RESUSCITATION TEST FIXTURE (LRTF) WITH NO ANOMALIES OR ERRORS EXHIBITED. A REVIEW OF THE PLATFORM'S ARCHIVE WAS PERFORMED AND FOUND MULTIPLE UA 45 FAULTS TO HAVE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 45 IS EXHIBITED WHEN THE LIFEBAND IS NOT FULLY EXTENDED, OR IF THE ENCODER IS NOT IN THE "HOME" POSITION. AS THERE WERE NO ISSUES IDENTIFIED DURING FUNCTIONAL TESTING ASSOCIATED WITH UA 45, THE ROOT CAUSE OF THE EXHIBITED UA 45 WAS DETERMINED TO BE THAT THE LIFEBAND WAS NOT FULLY EXTENDED, CAUSING THE ENCODER TO NOT BE AT THE "HOME" POSITION. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA 45 TO PREVENT PATIENT HARM. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE MOTOR COVER. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. IN SUMMARY, THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING A UA 45 WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM'S ARCHIVES; HOWEVER, THE COMPLAINT OF THE DRIVESHAFT APPEARING TO BE OFF BY 180 DEGREES WAS NOT CONFIRMED. THE UA 45 WAS UNABLE TO BE DUPLICATED DURING INVESTIGATION AND THE DRIVESHAFT WAS DETERMINED TO BE IN THE CORRECT POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM CONSISTENTLY DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. THE MESSAGE CLEARED WHEN THE CUSTOMER RESET THE DRIVESHAFT TO THE "HOME" POSITION; HOWEVER, THE UA 45 MESSAGE APPEARED AGAIN THE NEXT TIME THAT THE PLATFORM WAS POWERED ON. THE CUSTOMER MENTIONED THAT WHEN THEY TRIED TO ROTATE THE DRIVESHAFT TO THE "HOME" POSITION THE SECOND TIME, THE HOME POSITION WAS NOT SET PROPERLY TO WHERE THEY COULD INSERT THE LIFEBAND. IT APPEARED AS IF THE "HOME" POSITION WAS OFF BY 180 DEGREES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568293 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1