BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 13502664 · Received February 9, 2022

    Report

    Report Number
    3010617000-2022-00105
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Report Date
    February 9, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111065016
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT "THE FABRIC HOLDING THE LIFEBAND (LOT #161862) BAND CLIP WAS TORN, AND THE BAND CLIP WAS DETACHED" WAS CONFIRMED DURING THE VISUAL INSPECTION. THE ROOT CAUSE FOR THE REPORTED DAMAGE WAS DUE TO A MISSING PATCH ATTACHED TO THE BELT CLIP. THE PATCH PROTECTS THE LONG BELT AGAINST THE FRICTION GENERATED DURING THE ROTATION INTO THE PLATFORM SHAFT, LIKELY ATTRIBUTED TO THE ISOLATED INCIDENT DURING THE LIFEBAND ASSEMBLY. NO PREVIOUS REPORTS OF ASSEMBLY ERROR. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE STITCHES ON THE BELT NEAR THE BELT CLIP WERE SEPARATED AND THE BAND CLIP COMPLETELY DETACHED WITH NO PRESENCE OF THE PATCH ATTACHED TO THE CLIP. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED LIFEBAND DAMAGE. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR LIFEBAND WITH LOT# 161862.

    Description of Event or Problem · 0

    DURING SHIFT CHECK, THE CUSTOMER INSTALLED LIFEBAND#1 (LOT #161862) TO TEST THE AUTOPULSE PLATFORM (SN (B)(4)). AFTER PERFORMING A FEW COMPRESSIONS, THE AUTOPULSE PLATFORM STOPPED WORKING WITH AN UNUSUAL SOUND AND DISPLAYED AN UNKNOWN ERROR MESSAGE. THE CUSTOMER OBSERVED THAT THE FABRIC HOLDING THE LIFEBAND BAND CLIP WAS TORN, AND THE BAND CLIP WAS DETACHED. THE CUSTOMER REPLACED IT WITH ANOTHER LIFEBAND #2 (LOT #161862) AND RESTARTED THE PLATFORM. SHORTLY AFTER COMPRESSION, THE HINGED BELT GUARD ON LIFEBAND GOT BROKEN WITH AN UNUSUAL SOUND. AFTER THE REPORTED ISSUE, THE CUSTOMER TESTED THE AUTOPULSE PLATFORM WITH ANOTHER LIFEBAND, AND THE PLATFORM FUNCTIONED AS INTENDED. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00104 FOR THE AUTOPULSE PLATFORM (SN (B)(4)) MFR 3010617000-2022-00106 FOR THE LIFEBAND #2 (LOT #161862)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850516 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 161862 00849111065016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown