BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS IC PRO

    MDR report key: 14716134 · Received June 16, 2022

    Report

    Report Number
    3003832357-2022-00009
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)
    Product Code
    MWI
    UDI-DI
    05060472440297
    PMA / PMN Number
    K101264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DISPOSED THE PARTS.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER "TEMPUS IC LI-ION BATTERY EXPLODED WHILE BEING CHARGED BY TEMPUS BATTERY CHARGER". INITIAL EVALUATION BASED ON THE CUSTOMER COMMUNICATIONS REVEAL THAT TEMPUS IC PRO, THE AFFECTED PRODUCT BUILT & SHIPPED TO OUR CUSTOMER, US SOCOM (US SPECIAL FORCES), BACK IN 2011. ADVENTURE MEDICS, WHO REPORTED THIS COMPLAINT, PURCHASED EITHER FROM GOVT AUCTION OR FROM EBAY. THERE IS NO FURTHER EVALUATION POSSIBLE FOR THIS CASE SINCE CUSTOMER DISPOSED THE BATTERY DEBRIS AND THE PRODUCT IS END OF LIFE. CAUSE COULD NOT BE DETERMINED. CUSTOMER HAS BEEN INFORMED ABOUT PRODUCT END OF LIFE AND NO SUPPORT FROM PHILIPS FOR THE PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937655 TEMPUS IC PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI REMOTE DIAGNOSTIC TECHNOLOGIES (RDT) 00-1002 05060472440297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other