BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 1678193 · Received May 4, 2010

    Report

    Report Number
    1218950-2010-00633
    Event Type
    Death
    Date Received
    May 4, 2010
    Report Date
    April 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER REPORTED THAT WHILE MONITORING A PT, THEY GOT A LOW BATTERY ALERT. THE CUSTOMER HAS NOT YET STATED WHETHER THE DEVICE WAS A FACTOR IN THE PT OUTCOME. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT WHILE MONITORING A PT, THEY GOT A LOW BATTERY ALERT. THE CUSTOMER HAS NOT YET STATED WHETHER THE DEVICE WAS A FACTOR IN THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death