BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC

    MDR report key: 2954271 · Received January 9, 2013

    Report

    Report Number
    2183502-2012-00663
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    ACCORDING TO USER FACILITY, THE PARAPAC 200D WAS IN USE IN A PT FOR ANAESTHESIA AND VENTILATION WHEN THE OUTPUT AND INLET CONNECTORS OF THE VENTILATOR STARTED LEAKING. AN ALTERNATE SOURCE OF VENTILATION WAS USED ON THE PATIENT. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11463 PNEUPAC PARAPAC BTL SMITHS MEDICAL MD, INC. 12003V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK