BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4542153 · Received February 24, 2015

    Report

    Report Number
    3010617000-2015-00104
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Report Date
    January 26, 2015
    Manufacturer
    ZOLL CIRCULATION
    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

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND NO DAMAGE TO THE PLATFORM. THE REPORTED USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) WAS OBSERVED UPON POWER UP OF THE PLATFORM, THUS CONFIRMING THE REPORTED COMPLAINT. FURTHER INSPECTION IDENTIFIED THE CAUSE TO BE THAT THE TWO SCREWS OF THE LIFEBAND CLIP THAT HOLD THE LEVER PARALLEL TO THE SWITCH CASE WERE LOOSE. THE LIFEBAND CLIP DETECT SWITCH WAS READJUSTED BY TIGHTENING THE SCREWS AND NO OTHER USER ADVISORIES OR WARNINGS WERE OBSERVED. LOAD CELL CHARACTERIZATION TESTING WAS ALSO PERFORMED AND IT WAS FOUND THAT BOTH LOAD CELL MODULES ARE FUNCTIONING WITHIN SPECIFICATION. THE PLATFORM WAS ALSO RUN WITH A 95% PATIENT TEST FIXTURE (LRTF) FOR SEVERAL HOURS AND NO OTHER FAULTS WERE OBSERVED. EVEN THOUGH THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT DATE OF EVENT, A REVIEW OF THE PLATFORM'S ARCHIVE DATA SHOWED THAT MULTIPLE USER ADVISORIES (UAS) SUCH AS: 2 (COMPRESSION TRACKING ERROR), 12 (LIFEBAND NOT PRESENT), 20 (POSITION OUT OF RANGE) AND 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) OCCURRED ON (B)(6) 2015. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA2 IS EXHIBITED WHEN THE PLATFORM DETECTS A CHANGE IN LIFEBAND TENSION. THIS ADVISORY HAPPENS WHEN EITHER THE PATIENT OR THE LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. UA20 AND UA45 ARE BOTH EXHIBITED WHEN THE LIFEBAND IS NOT FULLY EXTENDED BEFORE PRESSING START. NO PARTS NEEDED TO BE REPLACED TO REMEDY THE CUSTOMER REPORTED COMPLAINT. HOWEVER, THE TWO SCREWS OF THE LIFEBAND CLIP RESET SWITCH, WHICH HOLD THE LEVER PARALLEL TO THE SWITCH CASE WERE TIGHTENED TO RESOLVE THE REPORTED USER ADVISORY (UA) 12. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED UPON FUNCTIONAL TESTING AS WELL AS DURING PLATFORM ARCHIVE REVIEW AND ATTRIBUTED TO THE TWO SCREWS OF THE LIFEBAND CLIP RESET SWITCH, WHICH HOLDS THE LEVER PARALLEL TO THE SWITCH CASE WERE LOOSE. FOLLOWING SERVICE, INCLUDING TIGHTENING THE TWO SCREWS, THE PLATFORM PASSED ALL TEST CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE REPORTED INFORMATION, THE PATIENT DID NOT ACHIEVE ROSC WITH EITHER MANUAL OR MECHANICAL COMPRESSION. REVIEW OF ALL AVAILABLE INFORMATION TO DATE, MEDICAL JUDGMENT AND CONFIRMATION FROM THE CUSTOMER, USE OF THE AUTOPULSE DEVICE DID NOT CAUSE OR CONTRIBUTE TO DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WEIGHING (B)(6), SUFFERED ACUTE SEPSIS LEADING TO CARDIAC ARREST. THIS INCIDENT OCCURRED IN THE ICU AT MEDICAL CENTER OF THE ROCKIES. THE PATIENT WAS BEING MONITORED AT THE TIME BY A BESIDE MONITOR, WHICH IMMEDIATELY SOUNDED AN ALARM TO NOTIFY THE CARE TEAM THAT THE PATIENT WAS IN DISTRESS. MANUAL CPR WAS PERFORMED BY MEMBERS OF THE CARE TEAM (EXACT LENGTH OF TIME WAS NOT PROVIDED). THE AUTOPULSE WAS LOCATED OUTSIDE THE PATIENT'S ROOM APPROXIMATELY 20 FEET AWAY. THE PATIENT WAS PLACED ONTO THE AUTOPULSE PLATFORM WITHOUT ANY ISSUES. TO ENSURE CORRECT PLACEMENT, THE USER CHECKED BOTH THE PATIENT AND LIFEBAND POSITIONS. THE AUTOPULSE PLATFORM FAILED TO INITIATE COMPRESSIONS AND IMMEDIATELY DISPLAYED A USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) MESSAGE. USER PULLED UP THE LIFEBAND AND PRESSED RESTART MULTIPLE TIMES, HOWEVER THE ISSUE WOULD NOT RESOLVE. USE OF THE AUTOPULSE WAS DISCONTINUED. MANUAL CPR WAS RESUMED FOR UNKNOWN LENGTH OF TIME. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NEVER ACHIEVED. THE PATIENT WAS PRONOUNCED BY THE CRITICAL CARE PHYSICIAN IN THE ICU. ADDITIONAL PATIENT HISTORY AND MEDICATIONS WERE NOT PROVIDED. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. CUSTOMER RECEIVED CONFIRMATION FROM THE ICU CARE TEAM, THAT THE AUTOPULSE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, FURTHER INFORMATION HAS NOT YET BEEN OBTAINED. PLEASE NOTE THAT CUSTOMER BELIEVES THAT THE DATE OF EVENT IS (B)(6) 2015, HOWEVER, MANUFACTURER HAS REQUESTED CONFIRMATION OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130911 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR