BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4624044 · Received March 23, 2015

    Report

    Report Number
    3010617000-2015-00180
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 2, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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, WHICH FOUND THAT THE LOAD PLATE COVER HAD HOLES IN IT, WHICH CAN AFFECT THE SEALING OF THE PLATFORM. THE AUTOPULSE PLATFORM WAS TURNED ON/OFF WITH NO OBSERVED PROBLEMS, HOWEVER IT WAS OBSERVED THAT THE SYSTEM FAN WAS NOT WORKING WHEN THE DEVICE WAS POWERED ON. THE PLATFORM WAS RUN WITH THE 95% PATIENT TEST FIXTURE (LRTF) FOR SEVERAL HOURS AND NO ANOMALIES OR ERRORS WERE EXHIBITED. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED. LOAD CELL CHARACTERIZATION TESTING WAS ALSO PERFORMED AND THE DATA AND GRAPH CONFIRMED THAT BOTH OF THE LOAD CELL MODULES ARE FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND WHICH FOUND THAT MULTIPLE USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) AND UA18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) FAULTS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA2 IS EXHIBITED WHEN THE PLATFORM DETECTS A CHANGE IN THE LIFEBAND TENSION. THIS ADVISORY HAPPENS WHEN EITHER THE PATIENT/OBJECT OR THE LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA18 IS EXHIBITED WHEN THE AUTOPULSE HAS DETECTED THAT EITHER THE PATIENT'S/OBJECTS CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP)/OBJECT OR THAT THERE IS NO PATIENT/OBJECT ON THE PLATFORM. BOTH UA'S ARE DESIGNED INTO THE PLATFORM TO PREVENT PATIENT HARM. NO PARTS WERE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT. ALL DAMAGE NOTED DURING THE VISUAL INSPECTION, UNRELATED TO THE REPORTED COMPLAINT WERE REPLACED. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM EXHIBITED A UA2 WAS CONFIRMED DURING REVIEW OF THE PLATFORM'S ARCHIVE. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR, AS AN INSIGNIFICANT LOAD CHANGE WAS RECORDED IN THE ARCHIVE, SUGGESTING THAT EITHER THERE WAS NO PATIENT/OBJECT ON THE PLATFORM, OR THAT THE PATIENT/OBJECT WAS TOO SMALL FOR THE PLATFORM TO FUNCTION CORRECTLY.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 03/10/2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY 2 (COMPRESSION TRACKING ERROR) MESSAGE, AFTER SEVERAL COMPRESSIONS. THE CUSTOMER ATTEMPTED TO FULLY EXTEND THE LIFEBAND AND PRESSED RESTART, HOWEVER THE SAME MESSAGE APPEARED ON THE LCD DISPLAY. THE CUSTOMER THEN EXCHANGED THE LIFEBAND, BUT THE ISSUE WOULD NOT RESOLVE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194212 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1