BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-VENTED HOSPITAL FULL FACE MASK

    MDR report key: 5049019 · Received September 2, 2015

    Report

    Report Number
    9611451-2015-00391
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 21, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT RT043 MASK WAS RETURNED TO FPH IN (B)(4) FOR EVALUATION, WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT A VENTED MASK BASE WAS ASSEMBLED INSTEAD OF A NON-VENTED MASK BASE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150213. CONCLUSION: THE INCORRECT ASSEMBLY OF THE MASK BASE WAS MOST LIKELY DUE TO AN INCORRECT LINE CLEARANCE DURING PRODUCTION. THE RELEVANT TEAM LEADER HAS BEEN REMINDED TO ENSURE CORRECT LINE CLEARANCE PROCEDURE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT043 MASK STATE THE FOLLOWING WARNINGS: THIS MASK MAY ONLY BE USED IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF. VERIFY THAT THE THERAPY DEVICE, INCLUDING ALARMS AND SAFETY SYSTEMS, HAVE BEEN VALIDATED PRIOR TO USE. THE THERAPY DEVICE MUST HAVE ADEQUATE ALARMS AND SAFETY SYSTEMS FOR DEVICE FAILURE. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE EVER RECEIVED FOR THE RT043 FULL FACE MASK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT043 NON VENTED HOSPITAL FULL FACE MASK CASE CONTAINED AN INCORRECT HOSPITAL FULL FACE VENTED MASK. THE WHOLE CASE WAS AFFECTED. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583513 NON-VENTED HOSPITAL FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT043 150213

    Patients

    Seq Age Sex Outcome Treatment
    1