BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1907981 · Received November 25, 2010

    Report

    Report Number
    9611451-2010-00719
    Event Type
    Malfunction
    Date Received
    November 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THIS FAULT MODE. RESULTS: THE HOSPITAL REPORTED THAT THEY ARE UNABLE TO ADJUST THE POWER LEVEL WHEN THE DEVICE IS ON MANUAL MODE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 060515. CONCLUSION: FISHER & PAYKEL HEALTHCARE IS UNABLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED FAULT AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER IT IS LIKELY THAT THE ENCODER, A BOARD COMPONENT WHICH PROVIDES CONTROL OF THE SET TEMPERATURE, SET POWER AND/OR ENGINEERING MODE SELECTIONS (DEPENDING ON WHICH MODE THE WARMER IS IN) WAS NOT MAKING SUFFICIENT CONTACT WITH THE BOARD. THE HOSPITAL ADVISED THAT, ALTHOUGH THE WARMER WAS RESPONDING INTERMITTENTLY TO THE DIAL, THE ALARMS WORKED PROPERLY WHEN TESTED. THIS TYPE OF FAULT IS EASILY DETECTED BY HOSPITAL STAFF MEMBERS, AS THE WARMER DISPLAY WILL REACT INTERMITTENTLY. THIS ALLOWS STAFF TO TAKE ACTION AND RECTIFY THE PROBLEM. FURTHERMORE, ALL AUDIBLE AND VISUAL ALARMS ARE STILL FULLY FUNCTIONAL. THE HOSPITAL CONFIRMED THAT THE UNIT DID ALARM ALTHOUGH THE TEMPERATURE CONTROL DID NOT FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL ((B)(6)) IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THEY CANNOT ADJUST THE POWER LEVEL ON AN IW931 INFANT WARMER WHEN IN MANUAL MODE. THE HOSPITAL REPORTED THAT WHEN THEY SET THE POWER LEVEL TO 90%, IT GOES BACK TO 100%. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL (B)(6) IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THEY CANNOT ADJUST THE POWER LEVEL ON AN IW931 INFANT WARMER WHEN IN MANUAL MODE. THE HOSPITAL REPORTED THAT WHEN THEY SET THE POWER LEVEL TO 90%, IT GOES BACK TO 100%. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW931AEU 060515

    Patients

    Seq Age Sex Outcome Treatment
    1