BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063442 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01125
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    September 10, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LIMITED TRANSLATED SYMPTOM INFO MADE AVAILABLE INDICATES "THERE IS AN ALARM WHEN IT IS IN USE". THERE WAS NO PATIENT INVOLVEMENT. IT WAS LATER CLARIFIED THAT THE DEVICE INTERMITTENTLY WAS REBOOTING. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM WAS CONFIRMED. THE OPTICAL SWITCH, CONTROL PCA, AND POWER PCA WERE REPLACED. THE CABLES WERE RECONNECTED AND THIS RESOLVED THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOMS AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE LIMITED TRANSLATED SYMPTOM INFO MADE AVAILABLE INDICATES "THERE IS AN ALARM WHEN IT IS IN USE." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127314 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1