BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWIVEL ADAPTER PEEP KEEP

    MDR report key: 75156 · Received March 12, 1997

    Report

    Report Number
    1217052-1997-00014
    Event Type
    Death
    Date Received
    March 12, 1997
    Date of Event
    February 2, 1997
    Product Code
    BZA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    H.6. METHOD, CODE 86(OTHER): THE 15MM TAPER OF THE RETURNED DEVICE WAS TESTED USING AN ISO CALIBRATED PLUG GAUGE. PRODUCT EVALUATION: SIMS EVALUATED THE TAPER OF THE RETURNED SWIVEL ADAPTER WITH AN ISO CALIBRATED GAUGE. EVALUATION CONFIRMED THAT THE 15MM TAPER MEETS THE ISO SPECIFICATION. CO THEREFORE CONCLUDED THAT THE ALLEGED DISCONNECTION OF THE VENTILATOR CIRCUIT FROM THE PATIENT'S TRACHEOSTOMY TUBE WAS NOT CAUSED BY A MALFUNCTION OF THE SIMS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIVEL ADAPTER PEEP KEEP AIRWAY CONNECTOR BZA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6MM SHILEY TRACHEOSTOMY TUBE| VENTILATOR AND CIRCUIT| HME