BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 13459386 · Received February 4, 2022

    Report

    Report Number
    3010617000-2022-00171
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111001571
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT "THE AUTOPULSE LIFEBAND (LOT # 170557) HAD BEEN TWISTED WAS CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED LIFEBAND. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS LIKELY INCORRECTLY INSTALLED LIFEBAND OR THE PATIENT DISPLACEMENT/ SHIFT ON THE PLATFORM DURING THE COMPRESSIONS. DURING THE VISUAL INSPECTION, OBSERVED THE BELT ON BAND 1 WAS TWISTED, THUS CONFIRMING THE CUSTOMER'S COMPLAINT. IN GENERAL, A TWISTED BELT SHOULD NOT AFFECT THE FUNCTIONALITY OF THE LIFEBAND. IN ADDITION, BOTH OF THE PROTECTIVE BAND SLEEVES WERE CUT/TORN OPEN BY THE CUSTOMER, UNRELATED TO THE REPORTED COMPLAINT. IT IS POSSIBLE, THE CUSTOMER WANTED TO VERIFY THE TWISTED LIFEBAND. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED DAMAGES ON THE RETURNED LIFEBAND. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR LIFEBAND WITH LOT# 170557.

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL (B)(4)) DISPLAYED FAULT CODE "16" (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. THE CUSTOMER IMMEDIATELY PERFORMED MANUAL CPR FOR THE REMAINDER OF THE EVENT. AFTER THE EVENT, THE CUSTOMER NOTICED THE LIFEBAND WAS TWISTED IN THE SLEEVE AND IT COULD NOT BE STRAIGHTEN, AND CUSTOMER DECIDED TO CUT OFF THE SLEEVE OF THE LIFEBAND. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2022-00111 FOR THE AUTOPULSE PLATFORM (SERIAL (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562987 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 170557 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown