BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PRESSURE MONITOR

    MDR report key: 6115007 · Received November 18, 2016

    Report

    Report Number
    1125873-2016-00044
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    VISICU, INC
    Product Code
    DXN
    PMA / PMN Number
    K041674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q&R HAS INVESTIGATED THE REPORTED FAILURE OF TELE HEALTH UNIT READING 204/83 VS 146/82 BY MANUAL READING. THIS COMPLAINT WAS NOT CONFIRMED. DEVICE WAS RETURNED TO THE 3RD PARTY LOGISTICS SUPPLIER (B)(4) ON OCTOBER 30, 2016. THE BLOOD PRESSURE (BP) CUFF DEVICE PASSED ALL PERFORMANCE SPECIFICATIONS FOR BP READINGS. INVESTIGATION SHOWED THAT DEVICE FAILED LEAKAGE TEST BUT THIS FAILURE WOULD NOT CONTRIBUTE TO THE FAILURE OF A HIGH BLOOD PRESSURE READING. Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE 10/17/18 TELE BP 8 AM 233/98 TELE RN ASSESSES, NO SYMPTOMS. REPEAT AT 11 AM 204/83, SHE DENIED SYMPTOMS BUT DR WAS NOTIFIED.. WHEN TELE RN CALLED TO ASSESS AGAIN, PT TOLD HER THAT T K FROM DR'S OFFICE TOLD HER TO TAKE AN EXTRA DOSE OF CLONIDINE ON SUNDAY EVENING. PT ALSO STATED THAT NURSE WAS THERE TODAY FOR SNV AND DID A MANUAL BP WHICH WAS 146/82 VERSUS TELE BP AT SAME TIME 204/83. TELE RN SENT AN EMAIL TO THE RN WHO DID THE VISIT TO CONFIRM THE DISCREPANCY BETWEEN THE 2 BP UNITS. TELE RN INFORMED PHILIPS AND ORDERED NEW BP UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764388 BLOOD PRESSURE MONITOR DXN VISICU, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR