BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FILL HUMIDIFICATION CHAMBER

    MDR report key: 5881438 · Received August 17, 2016

    Report

    Report Number
    9611451-2016-00451
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 18, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT MR225 MANUAL FILL HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4), WHERE THEY WERE VISUALLY INSPECTED AND PRESSURE TESTED (DEVICE 1). (B)(4). DEVICE 1: LOT: 160402, MANUFACTURED: 02 APRIL 2016. (B)(4). DEVICE 2: LOT: 160402, MANUFACTURED: 02 APRIL 2016. RESULTS: VISUAL INSPECTION OF DEVICE 1 REVEALED NO VISIBLE DAMAGE TO THE CHAMBER DOME. WHEN THE DEVICE WAS PRESSURE TESTED, THE RESULT WAS OUTSIDE SPECIFICATION, WITH LEAKS DETECTED AT THE BASE. VISUAL INSPECTION OF DEVICE 2 REVEALED A CRACK ON THE SIDE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR DEVICE 1 (LOT 160402). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR DEVICE 2 (LOT 160402). CONCLUSION: BASED ON OUR INVESTIGATION, THE DAMAGE IN DEVICE 1 WAS LIKELY CAUSED BY EXCESSIVE PRESSURE IN THE CHAMBER DOME DURING THERAPY. IN THE CASE OF DEVICE 2, THE CHAMBER DOME WAS MOST LIKELY SUBJECTED TO SOME FORM OF IMPACT DAMAGE DURING USE. ALL MR225 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT MR225 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED CHAMBERS BECAME DAMAGED AFTER RELEASE FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR225 MANUAL FILL HUMIDIFICATION CHAMBER STATE: "MAXIMUM OPERATING PRESSURE 20KPA." "IN THE EVENT OF THE CHAMBER LEAKING, SWITCH THE HUMIDIFICATION OFF AND REPLACE THE CHAMBER."

    Additional Manufacturer Narrative · 1

    (B)(4). THE TWO COMPLAINT MR225 MANUAL FILL HUMIDIFICATION CHAMBERS ARE CURRENTLY EN-ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION, TO DETERMINE IF THEY HAD A MALFUNCTION WHICH CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TWO INCIDENTS EACH INVOLVING AN MR225 MANUAL FILL HUMIDIFICATION CHAMBER LEAKING WATER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TWO INCIDENTS EACH INVOLVING AN MR225 MANUAL FILL HUMIDIFICATION CHAMBER LEAKING WATER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534336 MANUAL FILL HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR225

    Patients

    Seq Age Sex Outcome Treatment
    1