BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

    MDR report key: 5536454 · Received March 30, 2016

    Report

    Report Number
    1125873-2016-00023
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    February 29, 2016
    Report Date
    July 22, 2016
    Manufacturer
    PHILIPS VISICU
    Product Code
    DRG
    PMA / PMN Number
    K103214
    Removal / Correction Number
    1125873-05-13-16-012-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED IN THIS ISSUE. PHOTOGRAPH CONFIRMED THE ISSUE. INVESTIGATION IS UNDERWAY AND CAUSE AND CORRECTION WILL BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO PROVIDE AN UPDATE.

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE HISTORY OF THE LABEL, IT WAS DETERMINED THAT THE MEASUREMENT INTERVAL PRINTED ON THE LABEL APPLIED BY PHILIPS' SUPPLIER HAS BEEN INCORRECT SINCE THE LABEL'S ORIGINATION MORE THAN 10 YEARS AGO. FURTHER, PHILIPS INVESTIGATED THE LARGE AND SMALL BP CUFF LABELS AND DETERMINED THOSE WERE ALSO INCORRECT. A CORRECTION WAS MADE TO PRODUCT IN INVENTORY AND CHANGES WERE MADE TO THE LABEL TO CORRECT.

    Description of Event or Problem · 1

    CUSTOMER IDENTIFIED A PROBLEM WITH LABELING ON A BLOOD PRESSURE CUFF THAT (B)(4) SUPPLIED TO THE CUSTOMER. THE LABEL STATED THE MEASUREMENT WAS 19-31 CM. THE SIZE PRINTED ON THE CUFF STATES 24-36 CM. THE CUSTOMER CALLED FOR CLARIFICATION. THERE WAS NO PATIENT INVOLVED IN THIS ISSUE.

    Description of Event or Problem · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTED FOR ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191672 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 PHYSIOLOGICAL TRANSMITTER AND RECEIVER DRG PHILIPS VISICU M3815-80009

    Patients

    Seq Age Sex Outcome Treatment
    1