BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESYNC LEADWEAR

    MDR report key: 1414624 · Received July 1, 2009

    Report

    Report Number
    3003829651-2009-00010
    Event Type
    Other
    Date Received
    July 1, 2009
    Date of Event
    May 19, 2009
    Report Date
    June 30, 2009
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL QUESTIONING OF THE NURSE THAT REPORTED THE ISSUE, A POTENTIAL ROOT CAUSE WAS DETERMINED. THE LIFESYNC CORPORATION EMPLOYEE NOTED THAT A NUMBER OF PATIENTS AT THE HOSPITAL HAVE BEEN BATHED WHILE WEARING THE LIFESYNC LEADWEAR, AND THAT THIS PATIENT HAD RECENTLY BEEN BATHED PRIOR TO BEING MOVED. LIFESYNC PRODUCT LABELING INDICATES THAT THE LIFESYNC COMPONENTS SHOULD NOT BE IMMERSED IN LIQUID. LIFESYNC PRODUCT LABELING ALSO INFORMS THE CUSTOMER: "A LOSS OF SIGNAL CAN OCCUR IF EXCESS FORCE CAUSES DAMAGE TO A LIFESYNC LEADWEAR DISPOSABLE THAT IS STRETCHED DUE TO ELECTRODE PLACEMENT ON THE PATIENT. IN THE EVENT OF AN EMERGENCY SITUATION WHERE EXCESS FORCE WOULD BE APPLIED TO THE PATIENT (RESUSCITATION) PLEASE HAVE A SECONDARY METHOD OF MONITOR READILY AVAILABLE TO AVOID A PERIOD OF TIME WHERE THE PATIENT IS NOT MONITORED". THE FORCE OF MOVING THE QUADRIPLEGIC PATENT IN ADDITION TO THE POTENTIAL WEAKENING OF THE PRODUCT FROM IMMERSION IN WATER MAY HAVE CONTRIBUTED TO THE PRODUCT BREAKING. ALTHOUGH THE POTENTIAL FOR SERIOUS INJURY DOES EXIST FROM TIME OFF OF MONITOR DURING ASYSTOLE, NO DEATH OR SERIOUS INJURY WAS NOTED AS A RESULT OF THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009 A LIFESYNC CORPORATION EMPLOYEE WAS INFORMED BY A HOSPITAL EMPLOYEE THAT ON (B)(6) 2009 A PATIENT WAS TEMPORARILY OFF MONITOR DUE TO A BREAK IN THE LEADWEAR DURING MOVEMENT OF THE PATIENT. THE PATIENT WAS QUADRIPLEGIC AND HAD BEEN KNOWN TO TURN BLUE (HYPOXIC) DURING MOVEMENT. ANECDOTAL INFORMATION PROVIDED BY A HOSPITAL EMPLOYEE INDICATED THAT THE PATIENT HAD BEEN BATHED RECENTLY AND WAS BEING MOVED. THE LEADWEAR BROKE DURING MOVEMENT OF THE PATIENT. THE NURSE OBTAINED MORE LEADWEAR, PLACED IT ON THE PATIENT AND NOTED THAT THE PATIENT WAS IN ASYSTOLE. THE NURSE PROVIDED 5-10 CHEST COMPRESSIONS AND THE PATIENT'S HEART RATE RETURNED TO NORMAL. THE PATENT WAS LATER DISCHARGED WITH NO SERIOUS OR PERMANENT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNC LEADWEAR WIRELESS ECG SYSTEM DSA LIFESYNC CORPORATION LS-225 OR LS-226 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other