BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR MR8 PNEUMATIC

    MDR report key: 21392778 · Received February 18, 2025

    Report

    Report Number
    1625507-2025-00313
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 17, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00763000063962
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 PRODUCT ANALYSIS : EVALUATION COULD NOT REPRODUCE THE REPORTED MALFUNCTION OF OVERHEATING AS THE MAXIMUM TEMPERATURE OBSERVED WAS 89.1 F. B3: DATE OF INCIDENT OR ESTIMATED DATE OF INCIDENT WAS NOT PROVIDED TO THE MANUFACTURER. AWARE DATE USED AS DATE OF INCIDENT UNTIL FURTHER INFORMATION IS OBTAINED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125722 MOTOR MR8 PNEUMATIC MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS PM800-R 00763000063962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown