BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK PLUS 48H HOLTER REC MODEL 3100A

    MDR report key: 1436194 · Received May 8, 2009

    Report

    Report Number
    1218950-2009-00521
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Report Date
    April 9, 2009
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MWJ
    PMA / PMN Number
    K071733
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISAGREED WITH PORTIONS OF THE HOLTER MONITOR REPORT; THE REPORT STATED THAT THE PT'S HEART RATE WAS >300 BEATS PER MINUTE. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER DISAGREED WITH PORTIONS OF THE HOLTER MONITOR REPORT; THE REPORT STATED THAT THE PT'S HEART RATE WAS >300 BEATS PER MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITRAK PLUS 48H HOLTER REC MODEL 3100A MWJ PHILIPS HEALTHCARE M3732A

    Patients

    Seq Age Sex Outcome Treatment
    1