BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1781361 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82245
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS, MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY FOLLOWED BY A CONSTANT TONE AS A RESULT OF MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. IN ADDITION, MOISTURE DAMAGE WAS FOUND ON THE MOTOR AND BATTERY ASSEMBLY. FURTHER TESTING WAS NOT PERFORMED DUE TO THE FROZEN DISPLAY AND CONSTANT TONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. TROUBLESHOOTING WAS PERFORMED AND THE BUTTONS WERE UNRESPONSIVE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS, MED REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR