BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE VEST

    MDR report key: 1963005 · Received January 13, 2011

    Report

    Report Number
    1963005
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 13, 2011
    Manufacturer
    HILL-ROM
    Product Code
    BYI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE AIR GENERATOR PORTION OF THE VEST HAD SMOKE COMING OUT OF IT AND IT SMELT OF ELECTRICAL FIRE; THERE WAS NO INDICATION FROM THE OUTSIDE OF A FIRE. DEVICE WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM THE PATIENT. PATIENT APPEARS TO HAVE RECEIVED NO ILL EFFECT OF THE EVENT.CLEANING WAS ONLY DONE EXTERNALLY.======================MANUFACTURER RESPONSE FOR AIRWAY CLEARANCE SYSTEM, THE VEST======================WE HAVE ASKED FOR A DETAILED EXPLANATION FROM HILL ROM OF THE DEFECT OF THE UNIT. THE ONLY ANSWER THAT WE HAVE RECEIVED IS THAT THEY WILL HAVE TO REVIEW WITH THEIR LEGAL DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE VEST AIRWAY CLEARANCE SYSTEM BYI HILL-ROM R103 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR