BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4728918 · Received April 24, 2015

    Report

    Report Number
    3010617000-2015-00265
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    January 29, 2015
    Report Date
    January 29, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WHICH FOUND THAT THE TOP COVER AND FRONT ENCLOSURE WERE CRACKED. THE BOTTOM ENCLOSURE WAS ALSO FOUND TO BE DAMAGED AND THE RESTRAINT WIRES WERE CUT AND THE BATTERY CLIP WAS BENT. THE PLATFORM WAS FUNCTIONALLY TESTED WITH A LARGE RESUSCITATION TEST FIXTURE (LRTF) FOR 15 MINUTES, WITH NO USER ADVISORIES OR WARNINGS OBSERVED. A REVIEW OF THE PLATFORM'S ARCHIVE DATA WAS PERFORMED WHICH FOUND THAT A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA18 IS EXHIBITED WHEN THE AUTOPULSE HAS DETECTED THAT EITHER THE PATIENT'S CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE IS NO PATIENT ON THE PLATFORM. AS THE ARCHIVE DID NOT RECORD A CHANGE IN THE LOAD, IT HAS BEEN CONCLUDED THAT THERE WAS NO PATIENT ON THE PLATFORM WHEN THE UA WAS EXHIBITED. BASED ON THE INVESTIGATION THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE TOP COVER, BATTERY CLIP, FRONT ENCLOSURE AND BOTTOM ENCLOSURE. IN SUMMARY, THE INITIAL REPORTED COMPLAINT OF PHYSICAL DAMAGE TO THE PLATFORMS SHOULDER RESTRAINT WAS CONFIRMED DURING VISUAL INSPECTION AND MAY HAVE BEEN ATTRIBUTED TO USER ERROR, AS THE WIRES WERE CUT. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT ONE OF THE PATIENT SHOULDER RESTRAINT HOOPS WAS BROKEN AND NEEDS TO BE REPLACED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE AUTOPULSE PLATFORM WAS SUBSEQUENTLY RETURNED TO ZOLL FOR INVESTIGATION. DURING REVIEW OF THE PLATFORM'S ARCHIVE DATA, IT WAS OBSERVED THAT A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015. ALTHOUGH THE CUSTOMER DID NOT REPORT THIS, UA 18 IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273337 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1