BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063441 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01110
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    August 28, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER INITIALLY REPORTED A KEYSCAN PCA REPLACEMENT WITHOUT SPECIFIC INFO TO CONFIRM A DEVICE MALFUNCTION OR SAFETY ISSUE. INFO MADE AVAILABLE AT A LATER DATE IDENTIFIED THE ISSUE TO BE THE DEVICE HAD A BLANK DISPLAY UPON POWERING UP DURING OP CHECK. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY AN AUTHORIZED PHILIPS REPRESENTATIVE. THE ISSUE WAS DUPLICATED AND ISOLATED TO A FAULTY KEYSCAN PCA. THE KEYSCAN PCA WAS REPLACED TO RESOLVE THE SYMPTOM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. PHILIPS IS CONSIDERING THIS A MALFUNCTION OF THE KEYSCAN PCA. REPLACEMENT OF THE KEYSCAN PCA RESOLVED THE SYMPTOM. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED A KEYSCAN PCA REPLACEMENT WITHOUT SPECIFIC INFO TO CONFIRM A DEVICE MALFUNCTION OR SAFETY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129205 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1