BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 13535599 · Received February 15, 2022

    Report

    Report Number
    3012307300-2022-03403
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Report Date
    March 17, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6) ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO PATIENT INVOLVEMENT, THERE WAS NO PATIENT INJURY. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION, THE TOP CASE CORNERS WERE CRACKED, AND THE BOTTOM CASE BY L-BRACKET, AND BOTH PLUNGER CASES WERE CRACKED. AS A RESULT OF CHECKING THE LOG, IT REVEALED MAINTENANCE WAS RECOMMENDED. VISUAL INSPECTION, POWER UP PROCESS REPLICATED THE MAINTENANCE RECOMMENDED. BASED ON EVIDENCE AND INVESTIGATION, THE COMPLAINT ALLEGATION WAS DETERMINED THAT THE UNIT HAD BEEN DAMAGED BY THE CUSTOMER AND THE ANNUAL MAINTENANCE WAS DUE.

    Description of Event or Problem · 0

    BROKEN UPPER AND LOWER CASE-ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524444 MEDFUSION PUMP, INFUSION FRN ST PAUL 3500-500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown