BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    880 HUMIDIFICATION SYSTEM

    MDR report key: 1663384 · Received April 15, 2010

    Report

    Report Number
    9611451-2010-00223
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT SOLD IN THE USA BUT SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K073706. THE HOSPITAL REPORTED THAT THE BREATHING CIRCUIT WAS NOT AVAILABLE FOR INVESTIGATION BECAUSE IT HAD BEEN DISCARDED, HOWEVER, AN INVESTIGATION WAS CARRIED OUT BASED ON INFO PROVIDED BY THE HOSPITAL. FISHER & PAYKEL HEALTHCARE RECEIVED A COMMUNICATION FROM THE CRITICAL CARE ADVANCED PRACTICE NURSE / CLINICAL NURSE MANAGER AT THE HOSPITAL WHICH STATED THAT THE PT WAS ON A SET-UP WHICH INCLUDED HUMIDIFIED OXYGEN FOR ALMOST ONE WEEK AND WAS IMMOBILE. THE CRITICAL CARE ADVANCED PRACTICE NURSE / CLINICAL NURSE MANAGER REPORTED THAT THE PATIENT "HAS BEEN LAYING ON HIS CIRCUIT AS THE BURN IS ON HIS BACK...THIS IS AN ISSUE OF NURSING CARE AND NOT OF THE CIRCUIT." BASED ON THE F/U INFO PROVIDED BY THE HOSPITAL, THE ALLEGED PATIENT BURN WAS CAUSED BY THE PT LYING ON THE BREATHING CIRCUIT FOR AN EXTENDED PERIOD OF TIME. FISHER & PAYKEL HEALTHCARE HAS NOT RECEIVED ANY INFO WHICH SUGGESTS THAT A PRODUCT MALFUNCTION OCCURRED. THE USER INSTRUCTIONS PROVIDED WITH THE BREATHING CIRCUIT INCLUDE THE FOLLOWING WARNING: "DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS BLANKETS, TOWELS, OR BED LINEN, OR PLACE IN THE PATH OF RADIANT HEAT." THE HOSPITAL REPORTED THAT THEY DID NOT CONSIDER THE INJURY TO BE SERIOUS, NOR DID IT HAVE ANY EFFECT ON THE PT'S NURSING CARE.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED THAT THEY "HAD A BURN TO A PT ON THE BACK". THE HOSP STATED THAT THEY ARE "UNSURE OF WHEN IT ACTUALLY OCCURRED", BUT "WHEN THE PT WAS FOUND IN THE MORNING, THE BLISTERS WERE BURST AND ALL IN A ROW ACROSS THE BACK AT SCAPULA HEIGHT". THE HOSP ALSO REPORTED TO FISHER & PAYKEL HEALTHCARE THAT THE BURN HAD NO EFFECT ON THE PT'S NURSING CARE AND THEY DID NOT BELIEVE THAT THE INJURY WAS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 880 HUMIDIFICATION SYSTEM NONE BTT FISHER & PAYKEL HEALTHCARE, LTD. RT241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NASAL PRONGS| MR880 RESPIRATORY HUMIDIFIER