BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNOMEDICAL, INC. # 962-E

    MDR report key: 562115 · Received November 30, 2004

    Report

    Report Number
    MW1033875
    Event Type
    Injury
    Date Received
    November 30, 2004
    Date of Event
    November 23, 2004
    Report Date
    November 30, 2004
    Manufacturer
    UNOMEDICAL, INC.
    Product Code
    BZA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TRANSPORT, FROM OR TO PACU FOLLOWING UNEVENTFUL CLUB FEET REPAIR, PT DEVELOPED BILATERAL PNEUMOTHORAX AND HYPOXIA. IT WAS RECOGNIZED AND TREATED PROMPTLY WITH CHEST TUBE PLACEMENT. PT REMAINED INTUBATED/VENTILATED SECONDARY TO RE-EXPANSION PULMONARY EDEMA AND WAS ADMITTED (UNPLANNED) TO PICU. THE ROOT CAUSE OF THE EVENT WAS A MFG PROBLEM WITH A 22 MM ADAPTER CONNECTED TO AMBU BAG. THE ADAPTER WAS NOT PATENT (THIN PLASTIC MEMBRANE), THUS PREVENTING EXHALATION AND RESULTED IN SUBSEQUENT COMPLICATION. UPON FURTHER PRODUCT REVIEW RPTR FOUND 3 ADD'L UNITS WITH THE SAME DEFECT IN LOTS #04-40 AND 04-41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNOMEDICAL, INC. # 962-E 22 MM AIRWAY ADAPTER BZA UNOMEDICAL, INC. 962-E 04-40
    2 UNOMEDICAL, INC. # 962-E 22 MM AIRWAY ADAPTER BZA UNOMEDICAL, INC. 962-E 04-41

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R