BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX I MO

    MDR report key: 365490 · Received November 29, 2001

    Report

    Report Number
    1625507-2001-00850
    Event Type
    Malfunction
    Date Received
    November 29, 2001
    Report Date
    October 29, 2001
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    "LEAKING OIL" WAS STATED ON CUSOTMER REPAIR PAPERWORK. ON FOLLOW UP, IT WAS REPORTED THAT THE OIL LEAK WAS FOUND AFTER SURGERY. HOSPITAL REPRESENTATIVE THOUGHT THAT SOMEBODY MIGHT HAVE SUBMERGED AND WASHED THE MOTOR IN WATER AND THOUGHT THERE COULD BE WATER INSIDE THE MOTOR. REP JUST WANTED TO HAVE THE MOTOR SERVICED BEFORE PUTTING IT BACK INTO THE SERVICE. NO PT INJURY OCCURRED, NO OIL LEAKED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53912 MIDAS REX I MO PNEUMATIC SURGICAL DRILL, MIDAS HBB MEDTRONIC MIDAS REX NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA