BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 5408700 · Received February 3, 2016

    Report

    Report Number
    9611451-2016-00031
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    December 31, 2015
    Report Date
    January 5, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT219 ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. OUR ANALYSIS IS ALSO BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: VISUAL INSPECTION REVEALED THAT PART OF THE RETURNED BREATHING CIRCUIT HAD MELTED AND DEFORMED. THE HEATER WIRE AND THE TEMPERATURE PROBE CLIP WERE PRESSED ONTO THE MELTED TUBING MATERIAL. THE HOSPITAL REPORTED THAT THE SUBJECT BREATHING CIRCUIT WAS USED ON A PATIENT FOR AT LEAST 48 HOURS. IT WAS ALSO CONFIRMED BY THE HOSPITAL THAT THE BREATHING CIRCUIT WAS COVERED WITH A PILLOW THE ENTIRE TIME IT WAS USED ON THE PATIENT AND THAT THE PATIENT WAS LAYING ON THAT PILLOW. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150728. CONCLUSION: BASED ON THE RESULTS OF OUR INVESTIGATION AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL, THE REPORTED FAULT WAS DUE TO THE PILLOW THAT COVERED THE SUBJECT BREATHING CIRCUIT AND THE PATIENT LAYING ON THAT PILLOW. OUR USER INSTRUCTIONS SPECIFIES IN THE WARMING SECTION "DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH BLANKETS, TOWELS OR BED LINEN". NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT219 ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TUBE OF AN RT219 ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT ALLEGEDLY MELTED WHILE BEING USED ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) THAT THE TUBE OF AN RT219 ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT ALLEGEDLY MELTED WHILE BEING USED ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67078 ADULT BI-LEVEL INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT219 150728

    Patients

    Seq Age Sex Outcome Treatment
    1