BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2941984 · Received December 22, 2012

    Report

    Report Number
    1218950-2012-04241
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 4, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE NURSE DID AN OP CHECK WHILE THE DEVICE WAS ATTACHED TO THE PATIENT. THERE WAS NO NEGATIVE PATIENT IMPACT. THE CUSTOMER PERFORMED THEIR OWN INTERNAL INVESTIGATION AND PROVIDED RE-TRAINING ON PERFORMANCE OF THE OPERATIONAL CHECK. THE LABELING STATES TO "CONNECT A 50 OHM TEST LOAD TO THE PADS/PATIENT CABLE (INSTEAD OF PADS)." THE DEVICE REMAINS AT THE CUSTOMER SITE. RE-TRAINING WAS DONE BY THE CUSTOMER FOR THIS USE ISSUE. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NURSE DID AN OP CHECK WHILE THE DEVICE WAS ATTACHED TO THE PATIENT. THERE WAS NO NEGATIVE PATIENT IMPACT.

    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