BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER

    MDR report key: 6511829 · Received April 21, 2017

    Report

    Report Number
    3011137372-2017-00131
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    April 1, 2017
    Report Date
    April 5, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND A HOLE WAS OBSERVED ON THE AIR CUSHION ALONG THE EDGE OF THE HARD SHELL OF THE MASK. THE EDGE OF THE HARD SHELL WAS CHECKED AND NO FLASHING OR SHARP EDGES WERE FOUND. THE MASK WAS CHECKED PRIOR TO PACKAGING BY THE DOUBLE HAND PRESSING METHOD AND NO ISSUES WERE DETECTED. A DEFECT OF THIS TYPE WOULD BE DETECTED DURING THE INSPECTION PROCESS. A DHR REVIEW WAS PERFORMED ON THE LOT NUMBER REPORTED (161101), AND NO ISSUES WERE FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE DEFECT OCCURRED DURING TRANSPORTATION, AND IS CONSIDERED TO BE AN ISOLATED CASE. A CONCLUSION CODE COULD NOT BE FOUND.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE HEAD NURSE FOUND THE MASK OF THE DEVICE DEFLATED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE HEAD NURSE FOUND THE MASK OF THE DEVICE DEFLATED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293775 HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER VENTILATOR, EMERGENCY, MANUAL (RESUS BTM TELEFLEX MEDICAL 161101

    Patients

    Seq Age Sex Outcome Treatment
    1