BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5418236 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-03013
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    October 14, 2013
    Report Date
    October 14, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. (B)(4). RETURNED TO MANUFACTURER: (B)(4) 2013. THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED AND EXAMINED QTY (2) DDI PROBES P/N: 770876 REV. G, A24. INDEPENDENTLY INSTALLED BOTH PROBES INTO A FUNCTIONAL 3100A TEST VENT. WITH GREAT DIFFICULTY PER MODEL 3100A OSCILLATORY VENTILATOR DDI BOARD ASSEMBLY FUNCTIONAL CHECKOUT PROCEDURE, BOTH PROBES COULD BE CALIBRATED. BOTH PROBES HAD TO BE ROTATED TO GET THE TP1 0.0V TO COME IN. HAD THE DDI PROBES TESTED PER TEST PROCEDURE DDI SUB ASSY 3100A 767141 ON TEST FIXTURE 01-767141 AND FOUND THAT THEY BOTH FAILED THE TEST. COULD NOT DUPLICATE, THE REPORTED ISSUE. HOWEVER, HAD THE DDI PROBES TESTED PER TEST PROCEDURE DDI SUB ASSY 3100A 767141 ON TEST FIXTURE 01-767141 AND FOUND THAT THEY BOTH FAILED THE TEST. QTY (2) DEFECTIVE DDI PROBES P/N: 770876 REV. G, A24. THE EVENT IS CONSIDERED AN ISOLATED INCIDENT AND NO PREVENTIVE MEASURE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VOLTAGE WOULD NOT MOVE DURING DDI CALIBRATION. IT IS STAYING AT 2.1 VOLTS. CAREFUSION TECHNICAL SUPPORT REPRESENTATIVE ISSUED A REPLACEMENT DDI PROBE BOARD. CUSTOMER CALLED AGAIN ON (B)(6) 2013 AND REPORTED AFTER REPLACING THE DDI PROBE, THE ISSUE DID NOT RESOLVE; STILL CANNOT CALIBRATE THE DDI. THE VOLTAGE STAYS AT 14VOLTS WHEN IT SHOULD BE 2.4 VOLTS FOR FAR RIGHT ETC. THE DDI SCREEN IS BLANK. THE VOLTAGE IS STILL VERY HIGH. THE CUSTOMER IS RETURNING THE DDI PROBES. SUPPORT REP ISSUED A REPLACEMENT FOR THE DRIVER ASSEMBLY. PATIENT INVOLVEMENT IS UNKNOWN. THE CUSTOMER REPORTED ADDITIONALLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75811 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1