BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2961582 · Received February 11, 2013

    Report

    Report Number
    1219343-2013-00013
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K992723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE REPORT OF FLUID SPILL WAS NOT CONFIRMED, HOWEVER, THERE WAS A BURNING SMELL. THE MACHINE SMOKED, HAD ELECTRICAL ARCING AND BURNING SMELL. THE POWER SUPPLY WAS REPLACED AND UPGRADED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2013 TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "FLUID SPILL, NO POWER." NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59356 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1