BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 3083758 · Received April 29, 2013

    Report

    Report Number
    9611451-2013-00329
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR850AFU RESPIRATORY HUMIDIFIER WILL BE RETURNED TO FPH SERVICE CENTRE IN (B)(6) FOR INSPECTION. WE ARE ALSO IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY 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 HAVE INSPECTED THE COMPLAINT DEVICE AND COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION DONE ON THE SUBJECT MR850AFU RESPIRATORY HUMIDIFIER. METHOD: THE COMPLAINT MR850AFU WAS RETURNED TO FPH SERVICE CENTRE IN (B)(4) FOR INSPECTION. THE DEVICE WAS VISUALLY INSPECTED AND PERFORMANCE TESTED AS PER MR850 PRODUCT TECHNICAL MANUAL BY A TRAINED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INSPECTION RESULTS AND THE LIMITED INFORMATION PROVIDED BY THE HEALTHCARE FACILITY. RESULTS: THE RETURNED MR850 HUMIDIFIER WAS INSPECTED EXTERNALLY AND NO ISSUES WERE NOTED. IT ALSO PASSED THE PERFORMANCE CHECKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120905. CONCLUSION: NO FAULT WAS FOUND WITH THE SUBJECT MR850AFU HUMIDIFIER AS IT PASSED THE VISUAL INSPECTION AND PERFORMANCE CHECK. IT WAS RETURNED TO THE HEALTHCARE FACILITY AFTER THE INSPECTION. INVESTIGATION DONE ON THE BREATHING CIRCUIT KITS USED DURING THE REPORTED INCIDENT. METHODS: TWO BREATHING CIRCUIT KITS, WHICH WERE USED DURING THE REPORTED INCIDENT, WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE FIRST KIT CONTAINED AN RT330 INFANT CONTINUOUS FLOW BREATHING CIRCUIT, AN MR290 HUMIDIFICATION CHAMBER WITH LOT NUMBER 090507, A PRESSURE MANIFOLD, AND A GAS SUPPLY LINE. THE SECOND KIT CONTAINED AN RT330 INFANT CONTINUOUS FLOW BREATHING CIRCUIT, AN MR290 HUMIDIFICATION CHAMBER WITH LOT NUMBER 120816, AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA, A PRESSURE MANIFOLD, AND A GAS SUPPLY LINE. THE RETURNED DEVICES WERE VISUALLY INSPECTED. THE HEATER WIRE RESISTANCE OF THE RT330 INFANT BREATHING CIRCUITS WERE ALSO TESTED USING A MULTIMETER. BOTH BREATHING CIRCUIT KITS WERE SUBSEQUENTLY PERFORMANCE TESTED BY (B)(4). RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT KITS. THE HEATER WIRE RESISTANCE OF THE RT330 INFANT BREATHING CIRCUIT WAS WITHIN SPECIFICATION. NO FAULT WAS FOUND WITH THE BREATHING CIRCUIT KITS DURING PERFORMANCE TEST. NO AUDIBLE OR VISUAL ALARMS WERE OBSERVED ON THE MR850 RESPIRATORY HUMIDIFIERS. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUIT KITS AS IT PASSED THE VISUAL INSPECTION, PERFORMANCE CHECK, AND ELECTRICAL RESISTANCE TEST. BASED ON THE LIMITED INFORMATION WE RECEIVED FROM THE HEALTHCARE FACILITY, WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT OR HOW THE (B)(6) SUSTAINED FIRST DEGREE BURN ON THE CHECK. THE HEALTHCARE FACILITY LATER STATED THAT IT WAS NOT DUE TO THE RT330 OPTIFLOW JUNIOR TUBING. FURTHER INFORMATION RECEIVED REVEALED THAT THE (B)(6) CHEEK HAS SINCE HEALED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A (B)(6) ALLEGEDLY SUSTAINED A FIRST DEGREE BURN ON THE CHEEK WHILE USING AN MR850AFU RESPIRATORY HUMIDIFIER, AN RT330 OPTIFLOW JUNIOR TUBING KIT, AND A NEOBLENDER. THE (B)(6) WAS ALSO IN AN INCUBATOR WHEN THE INCIDENT OCCURRED. IT WAS FURTHER REPORTED THAT A BIAFINE CREAM WAS APPLIED TO THE BURN AND THAT THE INJURY HAS SINCE HEALED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A (B)(6) ALLEGEDLY SUSTAINED A FIRST DEGREE BURN ON THE CHEEK WHILE USING AN MR850AFU RESPIRATORY HUMIDIFIER, AN RT330 OPTIFLOW JUNIOR TUBING KIT, AND A NEOBLENDER. THE (B)(6) WAS ALSO IN AN INCUBATOR WHEN THE INCIDENT OCCURRED. IT WAS FURTHER REPORTED THAT A BIAFINE CREAM WAS APPLIED TO THE BURN AND THAT THE INJURY HAS SINCE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185441 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR850AFU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INCUBATOR| NEOBLENDER| MR850 RESPIRATORY HUMIDIFIER| INCUBATOR| RT330 OPTIFLOW JUNIOR TUBING KIT (LOT # 121016)| MR850 RESPIRATORY HUMIDIFIER| RT330 OPTIFLOW JUNIOR TUBING KIT (LOT # 121016)| NEOBLENDER