BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5527955 · Received March 26, 2016

    Report

    Report Number
    2021710-2016-03394
    Event Type
    Malfunction
    Date Received
    March 26, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, IT IS UNKNOWN WHETHER THERE IS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. ANY ADD'L INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV), DURING DISCONNECTION OF THE PATIENT CIRCUIT MACHINE THE UNIT WOULD NORMALLY STOP AND GENERATE AN ALARM, BUT THERE WAS NO AUDIBLE ALARM NOTED. THE CUSTOMER CROSSCHECKED THE ALLEGED DEFECTIVE ALARM BOARD WITH A REPLACEMENT AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183856 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION, INC 3100 HIGH FREQUENCY OSCILLATING VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1