BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1030547 · Received April 15, 2008

    Report

    Report Number
    2023050-2008-00026
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    August 7, 2007
    Report Date
    August 7, 2007
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H3: ANALYSIS: INVESTIGATION OF THE DEVICE HISTORY RECORD AND FINAL TEST DATA WAS CONDUCTED AND UNIT HAD PASSED ALL INSPECTIONS AT NEWPORT MEDICAL INSTRUMENTS BEFORE SHIPPING. PHYSICAL INVESTIGATION OF RETURNED UNIT FOUND THE CABLE TO PCB2106P WAS DISCONNECTED 100%. CABLE OR PCB BOARD HAD NO DAMAGE. CABLE WAS RECONNECTED AND ALARM FUNCTIONS RESUMED. CONCLUSION: DISCONNECTED CABLE FROM PCB2106P OCCURRED AFTER FINAL TEST AT NMI AND BEFORE DEALER RECEIPT OF UNIT. DEVICE HISTORY RECORD AND PAST TEST DATA WAS INVESTIGATED

    Description of Event or Problem · 1

    AS REPORTED, NO AUDIBLE ALARMS SOUNDED WHILE THE UNIT WAS IN USE, ONLY WHEN POWERED OFF AND ON. PLEASE NOTE THERE WAS NO PT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA