BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT

    MDR report key: 3011935 · Received March 19, 2013

    Report

    Report Number
    9611451-2013-00205
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION 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 COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE SUBJECT 900RD010 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT, WHICH WAS USED DURING THE REPORTED INCIDENT, WAS NOT RETURNED TO FPH AS IT HAD BEEN DISCARDED AT THE HOSPITAL FACILITY; HOWEVER, FOUR SAMPLES WERE RETURNED INSTEAD FOR FURTHER INSPECTION. ONE OF THE RETURNED SAMPLE WITHOUT LOT NUMBER WAS IN AN UNSEALED BAG, AND THE OTHER THREE WITH LOT NUMBER 120827 WERE UNUSED. ALL RETURNED SAMPLES WERE VISUALLY INSPECTED AND THE PEEP READINGS WERE CHECKED BY FITTING THEM INTO A WORKING RD900 NEOPUFF INFANT RESUSCITATOR. THE PEEP PRESSURES OF THE THREE UNUSED 900RD010 T-PIECE CIRCUITS WERE ALSO TESTED AT THE PRODUCTION LINE USING A PEEP TESTER. THE UNSEALED SAMPLE WAS NOT TAKE TO THE PRODUCTION LINE TO BE PEEP TESTED AS IT WAS CONSIDERED CONTAMINATED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED T-PIECE CIRCUITS. ALL PEEP READINGS WERE WITHIN SPECIFICATION. THE PRESSURE TEST RESULTS OF THE SAMPLES THAT WERE TESTED IN THE PRODUCT LINE WERE ALSO WITHIN SPECIFICATION. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION OF THE COMPLAINT T-PIECE CIRCUIT WAS NOT PROVIDED. CONCLUSION: NO FAULT WAS OBSERVED TO THE RETURNED SAMPLE T-PIECE CIRCUITS. THE PEEP CAP OF T-PIECE CIRCUIT CAN BE ADJUSTED DURING USE, DEPENDING ON THE PRESSURE SET BY THE PHYSICIAN AND ON THE HOSPITAL PROTOCOLS. THE USER INSTRUCTIONS (UI) THAT ACCOMPANY THE RD900 NEOPUFF INFANT RESUSCITATOR REMIND THE USER TO ENSURE THAT THE NEOPUFF IS FUNCTIONING CORRECTLY AND THAT THE PEEP CAP IS ADJUSTED TO THE DESIRED PEEP LEVEL. THE UI ALSO PROVIDE A WARNING "THE NEOPUFF INFANT RESUSCITATOR MUST ONLY BE USED AFTER CHECKING THAT CORRECT PRESSURES WILL BE DELIVERED TO THE BABY". THE 900RD010 T-PIECE CIRCUIT USER INSTRUCTIONS (UI) INDICATE IN PICTORIAL FORMAT THE CORRECT SET-UP, PIP AND PEEP LEVEL ADJUSTMENT, AND USE OF T-PIECE CIRCUIT BEFORE AND DURING RESUSCITATION. IT ALSO STATE THE FOLLOWING: "ENSURE PRESSURES ARE MONITORED THROUGHOUT RESUSCITATION". "THE T-PIECE CIRCUIT AND NEOPUFF ARE INTENDED FOR USE BY ADEQUATELY TRAINED MEDICAL PRACTITIONERS". ALL 900RD010 T-PIECE CIRCUITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE TO ENSURE THAT THEY MEET THE REQUIRED SPECIFICATIONS, AND THOSE THAT FAIL ARE REJECTED. THE FPH FIELD REPRESENTATIVE IS WORKING WITH THE HOSPITAL TO REMIND THEM OF THE WARNINGS AND RECOMMENDATIONS OUTLINED IN THE USER INSTRUCTIONS OF RD900 NEOPUFF INFANT RESUSCITATOR AND 900RD010 T-PIECE CIRCUIT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A 900RD010 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT, WHICH WAS CONNECTED TO A PATIENT WITHOUT FIRST CHECKING/SETTING THE PEEP, PRODUCED A PEEP VALUE OF APPROXIMATELY 15CMH2O. THIS HIGH PEEP LEVEL WAS NOTICED WITHIN THE FIRST FEW BREATHS OF THE PATIENT AND WAS IMMEDIATELY SET TO THE DESIRED LEVEL. THERE WAS NO PATIENT CONSEQUENCE. THE SUBJECT 900RD010 CIRCUIT WAS DISCARDED AT THE HOSPITAL FACILITY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A 900RD010 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT, WHICH WAS CONNECTED TO A PATIENT WITHOUT FIRST CHECKING/SETTING THE PEEP, PRODUCED A PEEP VALUE OF APPROXIMATELY 15CMH2O. THIS HIGH PEEP LEVEL WAS NOTICED WITHIN THE FIRST FEW BREATHS OF THE PATIENT AND WAS IMMEDIATELY SET TO THE DESIRED LEVEL. THERE WAS NO PATIENT CONSEQUENCE. THE SUBJECT 900RD010 CIRCUIT WAS DISCARDED AT THE HOSPITAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113398 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED 900RD010 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1