BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 3001643 · Received March 7, 2013

    Report

    Report Number
    1218950-2013-00691
    Event Type
    Death
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN UNSPECIFIED FAILURE DURING A PT EVENT. THE PT DIED, BUT THE CUSTOMER REPORTED THE DEVICE DID NOT PLAY A ROLE IN THE PT'S OUTCOME. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNSPECIFIED FAILURE DURING A PT EVENT. THE PT DIED, BUT THE CUSTOMER REPORTED THE DEVICE DID NOT PLAY A ROLE IN THE PT'S OUTCOME. THE DATE OF DEATH IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97970 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1