BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 HEADREST SYSTEM

    MDR report key: 7964742 · Received October 15, 2018

    Report

    Report Number
    7964742
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 18, 2018
    Report Date
    September 24, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT POSITIONED PRONE TO GET HEAD IN PROPER POSITION. PATIENT HEAD PLACED IN THE HEAD CLAMP AND FAILED TO LOCK, HEAD SLIPPED CAUSING A SCALP LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805834 DORO QR3 HEADREST SYSTEM HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL PRO MED INSTRUMENTS GMBH 1001.100

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Other