BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE/FLOW PROBE

    MDR report key: 2161008 · Received July 13, 2011

    Report

    Report Number
    9611451-2011-00406
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    January 3, 2011
    Report Date
    June 4, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) TEMPERATURE/FLOW PROBE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. WE ARE CURRENTLY 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 RECEIVE FURTHER INFORMATION FROM THE HEALTHCARE FACILITY AND HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, PHOTOGRAPHS (WHICH ARE TYPICAL EXAMPLES OF THEIR USUAL SET-UP) AND ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE FACILITY. RESULTS: A VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS OF THE FPH MR850 RESPIRATORY HUMIDIFIER DID NOT SHOW ANY DISCREPANCIES WITH THE HOSPITAL'S USUAL HUMIDIFIER SET-UP. THE HEALTHCARE FACILITY CONFIRMED THAT THE SUBJECT 900MR861 TEMPERATURE/FLOW PROBE WAS USED IN CONJUCTION WITH THE FPH MR850 RESPIRATORY HUMIDIFIER AND AN FPH RT210 ADULT-DUAL HEATED BREATHING CIRCUIT. THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE FPH DEVICES DURING USE ON THE PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THE FOLLOWING: "OCCLUSION MOST LIKELY RESULT OF INADEQUATE HUMIDIFICATION IN BREATHING CIRCUIT. MY RECALL IS THAT THE HUMIDIFIER WAS TURNED OFF DUE TO ALARMS AND NEVER FOLLOWED UP WITH. NOT SURE HOW LONG HUMIDIFIER WAS OFF." CONCLUSION: WITHOUT THE COMPLAINT DEVICE OR SUFFICIENT INFORMATION FROM THE HEALTHCARE FACILITY WE CANNOT PROVIDE ANY REASONABLE CONCLUSION ABOUT THE REPORTED FAULT. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE RECEIVED IN THE PAST TWO YEARS TO (B)(4) 2011.

    Description of Event or Problem · 1

    A UNIVERSITY IN (B)(6) REPORTED THE FOLLOWING TO THE FOOD AND DRUG ADMINISTRATION (FDA REPORT NUMBER: (B)(4)) INVOLVING A 900MR861 TEMPERATURE/FLOW PROBE: "PATIENT ON MECHANICAL VENTILATION, UNABLE TO PASS SUCTION CATH. DECREASED VENTILATION. PATIENT REQUIRED BRONCHOSCOPY REVEALING NEAR TOTAL OCCLUSION OF ETT WITH THICK DRIED SECRETIONS. ETT AND UPPER AIRWAYS WERE CLEARED WITH BRONCHOSCOPY AS WELL AS POSSIBLE THEN PATIENT WAS REINTUBATED OVER A BOUGE BY (B) (6) FELLOW WITHOUT INCIDENT. VENTILATION AND AIRWAY PATENCY WAS RETURNED TO NORMAL. UPON FURTHER INVESTIGATION AS TO THE CAUSE FOR THE INCIDENT, THE HEATER WIRE IS A CONSUMABLE ITEM. IT IS REPROCESSED BETWEEN PATIENTS. TWO SENSORS ARE CONNECTED INTO THE PATIENT CIRCUIT (NEAR THE CHAMBER AND AT THE PATIENT WYE) THAT MONITOR TEMPERATURE, FLOW, RH, AND FEED THE INFORMATION BACK TO THE HUMIDIFIER. OVER TIME THIS TEMPERATURE CABLE WEARS AND IS ONE OF THE ITEMS THE RT WOULD CHANGE IF THEY NOTICE PROBLEMS IN TEMPERATURE OR IF THE HUMIDIFIER ALARMS INDICATING THAT THE TEMPERATURE PROBE WAS THE PROBLEM".

    Description of Event or Problem · 1

    A (B)(6) REPORTED THE FOLLOWING TO THE FOOD AND DRUG ADMINISTRATION (B)(4) INVOLVING A (B)(4) TEMPERATURE/FLOW PROBE: "PATIENT ON MECHANICAL VENTILATION, UNABLE TO PASS SUCTION CATH. DECREASED VENTILATION. PATIENT REQUIRED BRONCHOSCOPY REVEALING NEAR TOTAL OCCLUSION OF ETT WITH THICK DRIED SECRETIONS. ETT AND UPPER AIRWAYS WERE CLEARED WITH BRONCHOSCOPY AS WELL AS POSSIBLE THEN PATIENT WAS REINTUBATED OVER A BOUGE BY (B) (6) FELLOW WITHOUT INCIDENT. VENTILATION AND AIRWAY PATENCY WAS RETURNED TO NORMAL. UPON FUTHER INVESTIGATION AS TO THE CAUSE FOR THE INCIDENT, THE HEATER WIRE IS A CONSUMABLE ITEM. IT IS REPROCESSED BETWEEN PATIENTS. TWO SENSORS ARE CONNECTED INTO THE PATIENT CIRCUIT (NEAR THE CHAMBER AND AT THE PATIENT WYE) THAT MONITOR TEMPERATURE, FLOW, RH, AND FEED THE INFORMATION BACK TO THE HUMIDIFIER. OVER TIME THIS TEMPERATURE CABLE WEARS AND IS ONE OF THE ITEMS THE RT WOULD CHANGE IF THEY NOTICE PROBLEMS IN TEMPERATURE OR IF THE HUMIDIFIER ALARMS INDICATING THAT THE TEMPERATURE PROBE WAS THE PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE/FLOW PROBE BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED 900MR861 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1