BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3755071 · Received April 16, 2014

    Report

    Report Number
    3003793491-2014-00191
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO FAULTS OR ERRORS WERE OBSERVED. A REVIEW OF THE PLATFORM ARCHIVE WAS PERFORMED AND FOUND THAT THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING A UA13, OCCURRED ON (B)(6) 2014 RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE ALSO SHOWS THAT MULTIPLE UA13 (BATTERY FAULT DETECTED (REPLACE BATTERY)) AND UNDER VOLTAGE <18V ERRORS OCCURRED ON (B)(6) 2014. THE UA13 AND UNDER VOLTAGE <18V ERRORS BOTH OCCURRED WHILE BATTERY S/N (B)(4) WAS IN USE IN THE PLATFORM. THE BATTERY'S RC AND VOLTAGE APPEAR TO BE WITHIN THE ACCEPTABLE RANGE, THEREFORE THE ROOT CAUSES OF THE UA13'S AND THE UNDER VOLTAGE <18V ERRORS WERE UNABLE TO BE DETERMINED. ON THE REPORTED EVENT DATE OF (B)(6) 2014, THE PLATFORM EXHIBITED MULTIPLE UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART), A UA20 (POSITION OUT OF RANGE (NO UNWIND)), A UA18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) AND ALSO A UA2 (COMPRESSION TRACKING ERROR) MESSAGES. ROOT CAUSES FOR THE REPORTED USER ADVISORIES COULD NOT BE DETERMINED HOWEVER, PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY (UA) 2 IS AN INDICATION THAT THE PATIENT OR THE LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY (UA) 18 IS AN INDICATION THAT THE PATIENT'S CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE WAS NO PATIENT ON THE PLATFORM. PER THE AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 USER GUIDE (PN: 12555-001), IF THE DRIVESHAFT IS NOT AT ITS HOME POSITION WHEN THE AUTOPULSE IS POWERED ON, A USER ADVISORY (45) WILL OCCUR. THIS USER ADVISORY WILL PERSIST UNTIL THE DRIVESHAFT IS RETURNED TO ITS HOME POSITION. THE USER ADVISORY 20 COULD ALSO BE ATTRIBUTED TO THE LIFEBAND NOT BEING COMPLETELY PULLED UP. PLEASE NOTE THAT THIS EVENT OCCURRED DURING TRAINING, THEREFORE THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE ARCHIVE WAS PERFORMED TO ASSESS THE CUSTOMER'S BATTERY MANAGEMENT PRACTICES. REVIEW OF THE ARCHIVE SHOWS THAT THE CUSTOMER IS PROPERLY MAINTAINING THEIR BATTERIES, HOWEVER THE ARCHIVE ALSO SHOWS THAT THE CUSTOMER IS NOT PERFORMING DAILY CHECKS AS RECOMMENDED IN THE IFU. THE POWER DISTRIBUTION BOARD (PDB) WAS REPLACED AS A PRECAUTION, AS THE UA13'S AND UNCOMMANDED SHUT OFFS COULD NOT BE REPRODUCED USING ZOLL TEST BATTERIES. AFTER REPLACING THE PDB, THE PLATFORM UNDERWENT THE RUN-IN TEST, USING A 95% PATIENT TEST FIXTURE WITH ZOLL TEST BATTERIES FOR SEVERAL HOURS AND NO FAULTS OR ERRORS WERE OBSERVED. THE SYSTEM UNDERWENT AND MEETS ALL TESTING CRITERIA. IN CONCLUSION, THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED THROUGH REVIEW OF THE ARCHIVE. THE POWER DISTRIBUTION BOARD (PDB) WAS REPLACED AS A PRECAUTION, AS THE PLATFORM FUNCTIONED AS INTENDED WITH ZOLL TEST BATTERIES PRIOR TO THE PDB BEING REPLACED. *BATTERY S/N (B)(4) WAS NOT RETURNED WITH THE PLATFORM, THEREFORE NO TESTING COULD BE PERFORMED USING THIS BATTERY. THE BATTERY WAS RETURNED TO ZOLL (B)(4) AND INVESTIGATED UNDER RELATED MFR 3003793491-2014-00192.

    Additional Manufacturer Narrative · 1

    COMPLAINANT ALSO REPORTED THAT PROPER BATTERY ROTATION IS BEING PERFORMED. PRODUCT IN COMPLAINT WAS INITIALLY RECEIVED BY ZOLL (B)(4). ZOLL (B)(4) WAS ABLE TO CONFIRM AND DUPLICATE THE CUSTOMER'S REPORTED COMPLAINT. PRODUCT IN COMPLAINT WILL BE RETURNED TO ZOLL (B)(4) FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: #3003793491-2014-00192 FOR AUTOPULSE LI-ION BATTERY SN (B)(4).

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TRAINING, THE AUTOPULSE PLATFORM DISPLAYED SEVERAL USER ADVISORY (UA) 13 (BATTERY FAULT DETECTED) "REPLACE BATTERY" MESSAGES, WITHIN 5 SECONDS OF POWERING THE DEVICE ON. THE DEVICE SUBSEQUENTLY POWERED OFF. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232296 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1