BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 3974699 · Received August 4, 2014

    Report

    Report Number
    3003793491-2014-00390
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE FOLLOWING RELATED MFR. REPORT #3003793491-2014-00391 FOR ISSUE REGARDING THE SECOND AUTOPULSE® LIFEBAND WITH SN: UNKNOWN. THE AUTOPULSE LIFEBAND IN COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE BOTTOM (PLASTIC PART) OF THE AUTOPULSE LIFEBAND BECAME DETACHED FROM THE AUTOPULSE PLATFORM AS IT WAS BEING SLID UNDER THE PATIENT. CUSTOMER STATED THAT THE AUTOPULSE UNIT WAS BEING SLID IN SIDEWAYS AS THIS OCCURRED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. AFTER THE REPORTED EVENT, CUSTOMER INSPECTED ALL OF THE LIFEBANDS IN THEIR SERVICE. DURING THEIR PRELIMINARY INVESTIGATION, THEY FOUND ONE LIFEBAND INSTALLED ONTO A UNIT THAT HAD A DEFECT OR WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454601 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION, INC 8700-0700 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1