BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION

    MDR report key: 621595 · Received July 12, 2005

    Report

    Report Number
    621595
    Event Type
    Malfunction
    Date Received
    July 12, 2005
    Date of Event
    July 10, 2005
    Report Date
    July 12, 2005
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PATIENT IN THE ICU WAS RECEIVING TREATMENT ON A LONG TERM RENTAL BIPAP UNIT WHEN THE UNIT EMITTED A LOUD BANG AND STOPPED WORKING. THE BIPAP WAS REMOVED FROM THE PATIENT AND REPLACED BY A SIMILAR VENTILATOR. THE BROKEN UNIT WAS KEPT AT THE BIOMEDICAL ENGINEERING DEPARTMENT UNTIL IT WAS PICKED UP AND REPLACED BY THE VENDOR.THIS UNIT IS THE PROPERTY OF FREEDOM MEDICAL. IT WAS EXAMINED BY THE VENDOR'S BIOMEDICAL TECHNICIAN AND DETERMINED THAT A COMPONENT (A CAPACITOR ) HAD SELF DESTRUCTED ON THE PRESSURE CONTROL BOARD. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE INCIDENT.

    Description of Event or Problem · 1

    THE DEVICE IN QUESTION WAS NOT EVALUATED OR REPAIRED BY RESPIRONICS INC. THIS DEVICE WAS THE PROPERTY OF FREEDOM MEDICAL INC., 219 WELSH POOL ROAD, EXTON, PENNYSLVANIA 19341, PHONE 610-903-0200. THE DEVICE WAS REPAIRED BY FREEDOM MEDICAL AND PUT BACK INTO USE. AS A RESULT NO FAILURE ANALYSIS OR LABORATORY TESTING WAS PERFORMED BY RESPIRONICS INC. DISCUSSION WITH THE USER FACILITY VERIFIED THAT THERE WAS NO PT HARM ASSOCIATED WITH THE REPORTED FAILURE. AFTER SPEAKING TO THE OWNER OF THE VENTILATOR, IT WAS DISCOVERED THAT THE REPORTED SHUTDOWN OF THE DEVICE WAS NOT A RESULT OF A FAILED CAPACITOR AS WAS ORIGINALLY REPORTED. THE TECHNICIAN WHO REPAIRED THE DEVICE VERIFIED THAT THE LOUD BANGING SOUND MENTIONED IN THE INITIAL COMPLAINT WAS A RESULT OF INTERNAL VALVE CLOSURE AND NOT THAT OF AN EXPLODING CAPACITOR. THE TECHNICIAN REPORTEDLY REPLACED AN INOPERATIVE PCS BOARD. BASED ON THE INFORMATION PROVIDED AND OUR INVESTIGATION, WE HAVE CONCLUDED THAT THIS FAILURE WOULD BE UNLIKELY TO CAUSE OR CONTRIBUTE TO PATIENT HARM IF IT WERE TO RECUR. THE SERVICE MANUAL AND THE CLINICAL MANUAL FOR THE DEVICE ARE PROVIDED. THERE MANUALS PROVIDE DIRECTIONS FOR USE, WARNINGS AND CAUTION STATMENTS, AND THE TECHNICAL SPECIFICATIONS FOR THE DEVICE. THERE HAVE BEEN NO MODIFICATIONS MADE TO THE DEVICE THAT ARE PERTINENT TO THIS EVENT OR REPORTED FAILURE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION POSITIVE AIRWAY PRESSURE UNIT, BI-LEVEL CBK RESPIRONICS INC. VISION *

    Patients

    Seq Age Sex Outcome Treatment
    1 *