BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS+ 9000

    MDR report key: 2854514 · Received November 29, 2012

    Report

    Report Number
    1219343-2012-00176
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK050047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PCB BOARD WAS INSPECTED. THE ODOR OF SMOKE WAS EVIDENT. A COMPONENT ON THE BOARD WAS BURNED WITH SOOT FOUND AROUND IT. THE COMPONENT WAS ALSO MELTED AND DEFORMED. A POSSIBLE ROOT CAUSE WAS TOO MUCH VOLTAGE SENT TO THE BOARD DUE TO A FAULTY CONNECTION AT THE POWER SOURCE. (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(6) 2012, FOR A PCS2 DEVICE "WHEN MACHINE WAS TURNED ON ELECTRICAL SMELL WAS PRODUCED. DISPLAY DID COME ON. NO OPERATOR/DONOR INJURIES ASSOCIATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCS+ 9000 GKT HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1