BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONNET MIDLINE

    MDR report key: 1951802 · Received January 6, 2011

    Report

    Report Number
    9611451-2011-00018
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: BC306 NOT BC305 INFANT BONNETS. DEVICE MANUFACTURE DATE: 2010-09. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: 2010-09. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) NOT (B)(4) INFANT BONNETS. METHOD: FIVE COMPLAINT BONNETS WERE RETURNED, FOUR OF THE BONNETS WERE RETURNED SEALED. THE BONNETS WERE VISUALLY INSPECTED AND STRETCHED TO TEST FOR ELASTICITY/RESTORING FORCE. RESULTS: THE VISUAL INSPECTION REVEALED NO DAMAGES TO THE BONNETS. BOTH THE SEALED AND UNSEALED BONNETS WERE STRETCHED AND THE BONNETS RESTORED TO THEIR ORIGINAL SHAPE, NO DEFORMATION WAS OBSERVED AND THE BONNETS WERE MEASURED AND WITHIN SPECIFICATION FOR THIS PRODUCT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE BONNETS ARE USED TO HOLD THE NASAL TUBING IN PLACE AND PREVENT THE NASAL PRONGS FROM MOVING. THERE WERE NO FAULTS FOUND WITH THE RETURNED BONNETS. THE HOSPITAL HAS REPORTED THAT THEY WERE NOT REPORTING THIS WITH REGARD TO ANY PARTICULAR COMPLAINT BUT RATHER RAISING THIS AS A GENERAL CONCERN ABOUT THE BONNET MATERIAL. REPLACEMENT BONNETS HAVE BEEN SUPPLIED TO THE HOSPITAL AND NO FURTHER COMPLAINTS HAVE BEEN RECEIVED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BC306 INFANT BONNETS WERE LACKING IN ELASTIC RESTORING FORCE, ALLOWING THE INFANTS TO MOVE THEIR HEADS "SO THE NASAL PRONGS DON'T STAY INSIDE THE NOSE." NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BC306 INFANT BONNETS WERE LACKING IN ELASTIC RESTORING FORCE, ALLOWING THE INFANTS TO MOVE THEIR HEADS "SO THE NASAL PRONGS DON'T STAY INSIDE THE NOSE". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BC305 INFANT BONNETS WERE LACKING IN ELASTIC RESTORING FORCE, ALLOWING THE INFANTS TO MOVE THEIR HEADS "SO THE NASAL PRONGS DON'T STAY INSIDE THE NOSE". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONNET MIDLINE BZO BZO FISHER & PAYKEL HEALTHCARE LTD BC306-05 2010-09

    Patients

    Seq Age Sex Outcome Treatment
    1