BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DINAMAP PROCARE SERIES MONITOR

    MDR report key: 1856292 · Received September 9, 2010

    Report

    Report Number
    9613557-2010-00006
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DINAMAP DEVICE IDENTIFICATION INFO WAS NOT PROVIDED. THE AFFECTED POWER CORDS ARE FROM WELL SHIN, PART NUMBER 316601. THE DINAMAP DEVICE IDENTIFICATION INFO WAS NOT PROVIDED, THEREFORE THE EXACT 510K NUMBER IS UNK. DINAMAP PROCARE SERIES 510K NUMBERS INCLUDE K014255 AND K022193. THE DEVICE MANUFACTURE DATE IS UNK. THE CUSTOMER STATED THAT THE ISSUE WAS NOTED IN ONE BATCH OF DINAMAP PROCARE MONITORS THAT WERE SUPPLIED APPROXIMATELY TWO YEARS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON APPROXIMATELY TWO DINAMAP PROCARE MONITORS, A SMALL HOLE WAS BURNED IN THE POWER CORD NEAR THE AREA WHERE THE CORD MEETS THE PLUG. NO INJURY WAS REPORTED. THIS IS THE SECOND OF TWO REPORTS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DINAMAP PROCARE SERIES MONITOR PHYSIOLOGICAL PT MONITOR MWI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1