BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACLAIM/FLEXIFIT NASAL MASK

    MDR report key: 1930855 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00752
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT PRODUCT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, HOWEVER AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER ORDERED A SHIPMENT OF (B)(4) (REPLACEMENT MASK FOAM AND SEAL KIT, SIZE SMALL). INITIALLY THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE THESE SPARE PARTS, BUT LATER REPORTED THAT THEY HAD FOUND THEM IN A BOX LABELLED (B)(4) (REPLACEMENT MASK FOAM AND SEAL KIT, SIZE LARGE). THIS PRODUCT COMPLAINT IS RELATED TO THE LABEL ON THE PRODUCT SHIPPING BOX. THE SPARE MASK FOAM AND SEAL KITS ARE INDIVIDUALLY PACKAGED INSIDE OF THE SHIPPING BOX. EACH REPLACEMENT KIT IS LABELLED IN ADDITION TO THE LABEL ON THE OUTSIDE BOX, THUS ALLOWING THE USER TO IDENTIFY WHICH SIZE KITS THEY HAVE RECEIVED. AFTER FINDING THAT THEY HAD RECEIVED THE (B)(4) SMALL SIZE REPLACEMENT KITS (IN A (B)(4) BOX), THE CUSTOMER HAS KEPT THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE'S COMPLAINT IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT A BOX OF (B)(4) SPARE FOAM CUSHION AND SILICONE SEAL SETS FOR CPAP MASKS WAS LABELLED INCORRECTLY (THE WRONG SIZE WAS INDICATED ON THE BOX). NOTE: THE (B)(4) SPARE PARTS ARE FOR USE WITH THE HC401 ACLAIM OR FLEXIFIT HC405 NASAL MASKS.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT A BOX OF 900HC427 SPARE FOAM CUSHION AND SILICONE SEAL SETS FOR CPAP MASKS WAS LABELED INCORRECTLY (THE WRONG SIZE WAS INDICATED ON THE BOX). NOTE: THE 900HC427 SPARE PARTS ARE FOR USE WITH THE HC401 ACCLAIM OR FLEXIFIT HC405 NASAL MASKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACLAIM/FLEXIFIT NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LIMITED HC401 OR HC405 (MASK) 100825

    Patients

    Seq Age Sex Outcome Treatment
    1