BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT INTERFACE HEADGEAR

    MDR report key: 2250375 · Received September 15, 2011

    Report

    Report Number
    9611451-2011-00561
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) INFANT INTERFACE HEADGEAR IS NOT EXPECTED TO BE RETURNED TO (B)(4) FOR INVESTIGATION AS IT HAS BEEN DESTROYED BY THE HOSPITAL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL. THE FPH INFANT INTERFACE HEADGEAR IS DESIGNED TO BE USED IN CONJUNCTION WITH THE INFANT INTERFACE NASAL TUBING, WHICH IS PART OF THE INFANT INTERFACE PRODUCT FAMILY. THE FPH INFANT INTERFACE HEADGEAR USER INSTRUCTIONS INDICATE IN PICTORIAL FORM THE CORRECT SET-UP AND USE/FITTING OF THE HEADGEAR, AND STATE THE FOLLOWING: "DO NOT OVER TIGHTEN THE INFANT HEADGEAR STRAPS." "THE FISHER & PAYKEL PATIENT INTERFACE SYSTEM IS INTENDED FOR USE BY ADEQUATELY TRAINED MEDICAL PRACTITIONERS. PLEASE CONTACT A F&P REPRESENTATIVE FOR SUGGESTED TRAINING MATERIAL." HOSPITAL STAFF STATED THAT THE INFANT WAS ACTIVE AND KEPT ON RUBBING HER FOREHEAD AGAINST THE BED, WHICH MAY HAVE CAUSED THE REPORTED DECUBITUS ULCER ON THE FOREHEAD. THE FOLLOWING INSTRUCTION, WHICH IS INCLUDED IN THE INFANT INTERFACE USER INSTRUCTIONS, ADDRESSES THE ISSUE OF PATIENT MOVEMENT: "THE KEY TO A SUCCESSFUL SETUP IS KEEPING THE NASAL TUBING IN PLACE. ENSURE THE WEIGHT OF THE CIRCUIT IS SUPPORTED TO REDUCE TENSION ON THE NASAL TUBING. THE CIRCUIT MUST HAVE FREE MOVEMENT TO ALLOW THE BABY'S HEAD TO MOVE WITHOUT RESTRICTION."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BC328 HAD BEEN DESTROYED AT THE HOSPITAL. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A FEMALE NEWBORN INFANT ALLEGEDLY DEVELOPED A DECUBITUS ULCER (BED SORE) ON THE FOREHEAD WHILE USING A (B)(4) INFANT INTERFACE HEADGEAR.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A FEMALE NEWBORN INFANT ALLEGEDLY DEVELOPED A DECUBITUS ULCER ON THE FOREHEAD WHILE USING A BC328 INFANT INTERFACE HEADGEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTERFACE HEADGEAR BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED BC328 081117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other