BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70

    MDR report key: 3250768 · Received July 25, 2013

    Report

    Report Number
    3250768
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 25, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A CRITICAL PATIENT IN THE EMERGENCY DEPARTMENT WAS IN THE PROCESS OF BEING TRANSFERRED PER CART TO AN INPATIENT UNIT. THE RESPIRATORY THERAPIST ASSEMBLED THE HT70 TRANSPORT VENTILATOR (ON PORTABLE WHEEL CART) AND NOTICED THE HT70 HANDLE WAS VISIBLY CRACKED. AS THE TRANSPORT TEAM STARTED TO MOVE THE PATIENT THE RESPIRATORY THERAPIST GRABBED THE HT70 HANDLE AND ATTEMPTED TO PUSH THE PORTABLE VENTILATOR. THE HT70 UNIT DID NOT MOVE. THE HANDLE BROKE FURTHER AND THE UNIT FELL OVER CUTTING THE RESPIRATORY THERAPIST'S HAND.OUR HOSPITAL HAS BEEN EXPERIENCING ON-GOING ISSUES WITH THE HANDLES CRACKING ON ALL 5 OF OUR HT70 UNITS. THE HANDLES HAVE BEEN REPLACED BY OUR BIOMED DEPARTMENT SEVERAL TIMES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TRANSFER OF CRITICALLY ILL PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348505 HT70 VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *