BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2170834 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01769
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER CONTACTED PHILIPS WITH QUESTIONS ABOUT TRANSCUTANEOUS PACING. THE CUSTOMER ASKED QUESTIONS ABOUT DERIVATION OF ECG FOR PACING VIA PADS. THERE WAS NO NEGATIVE PATIENT IMPACT. THE CUSTOMER WAS WITH PROVIDED INFORMATION ABOUT TRANSCUTANEOUS PACING, THAT DEMAND MODE PACING REQUIRES LEADS ECG INPUT. PACE PULSES ARE DELIVERED THROUGH THE MULTIFUNCTION ELECTRODE PADS. HOWEVER, THE PADS CANNOT BE USED TO MONITOR THE ECG AND DELIVER PACE PULSES SIMULTANEOUSLY. THERE WAS NO REPORT OF ANY FAILED OPERATIONAL CHECKS. THIS WAS A USE ISSUE RELATED TO PACING.

    Description of Event or Problem · 1

    THIS CUSTOMER CONTACTED PHILIPS WITH QUESTIONS ABOUT TRANSCUTANEOUS PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1