BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1989488 · Received February 14, 2011

    Report

    Report Number
    9611451-2011-00075
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K020332. MANUFACTURER NARRATIVE: METHOD: THE RETURNED RT125 INFANT BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR THE REPORTED LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED WITH THE RETURNED INFANT CIRCUIT. THE PRESSURE TEST RESULTS WERE WITHIN SPECIFICATIONS. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED RT125 INFANT BREATHING CIRCUIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY A VENTILATOR ALARM. THE USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. SET APPROPRIATE VENTILATOR ALARMS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K). THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K20332. MANUFACTURER NARRATIVE. THE COMPLAINT DEVICE HAS ONLY RECENTLY BEEN RETURNED TO FPH (B)(4) AND IS CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED BETWEEN THE HEATER MODULE AND ELBOW ADAPTER OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED BETWEEN THE HEATER MODULE AND ELBOW ADAPTER OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT125 100810

    Patients

    Seq Age Sex Outcome Treatment
    1