BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3063198 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01069
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE FAILED TO POWER UP. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVALUATION AND REPAIR. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS LOCALIZED TO THE OPTICAL SWITCH. THE OPTICAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED SYMPTOMS. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND WAS RETURNED TO THE CUSTOMER SITE FOR USE. HISTORICAL DATA REVIEW: A REVIEW OF MONTHLY SIMILAR COMPLAINT FREQUENCIES OVER THE LAST 12 MONTHS FROM THE ATTACHED TRENDING FOUND NO UNFAVORABLE TREND. THIS COMPLAINT DOES NOT INVOLVE AN UNRESOLVED PROBLEM, REPEATING ISSUE, OR OBSERVATION OF POOR QUALITY. THIS IS NOT AN EARLY LIFE FAILURE. NO RELATED CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THERE IS NO UNFAVORABLE TREND. THIS COMPLAINT DOES NOT INDICATE THE PRESENCE OF A SYSTEMIC PROBLEM OR EMERGING ISSUE. THIS WAS A MALFUNCTION OF THE OPTICAL SWITCH. REPLACEMENT OF THE OPTICAL SWITCH RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO POWER UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126636 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1