BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPB

    MDR report key: 355704 · Received October 10, 2001

    Report

    Report Number
    8020893-2001-00012
    Event Type
    Malfunction
    Date Received
    October 10, 2001
    Date of Event
    February 15, 2001
    Report Date
    October 10, 2001
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY HAD A PRE-PATIENT TESTING FAILURE AND ERROR CODE. THERE WAS NO PT INVOLVEMENT OR HARM FOR THE REPORT. DURING THE INSPECTION AND EVAL AT THE FACILITY, BY THE MALLINCKRODT NELLCOR PURITAN BENNETT CUSTOMER SERVICE ENGINEER NOTED, A "WHITE RESIDUE ON OUTSIDE OF FLOW SENSOR AND SAFTEY VALVE". THE DEVICE WAS REPAIRED, PASSED EXTENDED TESTING AND WAS RETURNED TO SERVICE. DURING A LATER SUBSEQUENT EVAL ON THE 10TH SEPTEMBER OF THE REMOVED COMPONENT IN THE LAB, IT WAS FOUND THAT THE SAFTEY VALVE EXHIBITED INCREASED OPENING PRESSURE DURING EVALUATION EXTENDED SELF TEST AND A "RUST" LIKE APPEARING CONTAMINATION ON THE VALVE. THE INVESTIGATION OF THE SERVICE HISTORY OF THE DEVICE REVEALED THAT APPROX TWO WEEKS PRIOR TO THE COMPLAINT, THERE WAS A REPORT OF THE USER OVERFILLING THE (NON NELLCOR PURITAN BENNETT) HUMIDIFIER IN THE PT SERVICE CIRCUIT, FILLING THE CIRCUIT WITH WATER AND CAUSING AN "OCCLUSION ALARM". IT IS UNKNOWN WHAT LIQUID WAS USED FOR HUMIDIFICATION. ACCORDING TO THE FACILITY REPORTER, THE DEVICE HAD BEEN IN USE WITH NO REPORTED ISSUES AFTER THE OVERFILLING OF THE HUMIDIFIER UNTIL THE LATER TESTING SHOWED THE ERROR CODES. THE CSE WAS CALLED FOR EVAL AND REPAIRS. THE USER FACILITY REPORTS THAT THEY HAVE CHANGED TYPE AND BRAND OF HUMIDIFIERS TO PREVENT RECURRENCE OF ACCIDENTAL OVERFILLING. INITIAL INFO REC'D VERIFIED NO PT HARM OR TREATMENT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45676 NPB VENTILATOR CBK NELLCOR PURITAN BENNETT IRE. 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA