BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1894517 · Received November 9, 2010

    Report

    Report Number
    9611451-2010-00681
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4), LOT NUMBER: 090901, DATE OF MANUFACTURE: 09/01/2009; (B)(4), 090901, 09/01/2009; (B)(4), 090820, 08/20/2009; (B)(4), 090820, 08/20/2009; (B)(4), 090820, 08/20/2009; (B)(4), 090820, 08/20/2009. ALTHOUGH THE COMPLAINT WARMERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, FISHER & PAYKEL HEALTHCARE WORKED CLOSELY WITH THE CUSTOMER TO DETERMINE THE CAUSE OF THE STABILIZER WEIGHT WHICH WAS NOT FIRMLY SECURED TO THE POLE ASSEMBLY. FURTHER INFORMATION PROVIDED BY THE DISTRIBUTOR CLARIFIED THAT THE POLE AND STABILIZER WEIGHT COULD BE SECURED FIRMLY, HOWEVER "WHILE TWISTING THE POLE TO TWIST THE WARMER HEAD, AND AFTER MANY TIMES OF TWISTING, THE LINK BETWEEN THE POLE AND STABILIZER WEIGHT BECOMES LOOSE, AS IF [THE USERS] ARE UNSCREWING THE POLE FROM THE STABILIZER WEIGHT". ON A PROPERLY ASSEMBLED INFANT WARMER, THE HEAD ALONE CAN BE SWIVEL OR ROTATE FREELY WITHOUT TWISTING THE POLE. IN ADDITION, THE UPPER HALF OF THE EXTENDIBLE POLE CAN BE ROTATED RELATIVE TO THE LOWER HALF, IF REQUIRED. THIS ALLOWS THE USER TO ROTATE THE WARMER CONTROLLER OR WARMER HEAD WITHOUT UNSCREWING THE POLE. BASED ON THE INFORMATION PROVIDED, IT IS LIKELY THAT THE PIVOT NUT IN THE WARMER HEAD WAS OVERTIGHTENED, PREVENTING FREE ROTATION WITHOUT TWISTING THE ENTIRE POLE, WHICH CAUSED THE POLE AND STABILIZER CONNECTION TO BECOME LOOSE. THE ASSEMBLY INSTRUCTIONS FOR THE IW910 INFANT WARMER STATE THE FOLLOWING: "CHECK THAT THE HEAD ROTATES FREELY BUT IS NOT TOO LOOSE". IT WAS ALSO REPORTED THAT IT WAS DIFFICULT TO ADJUST THE HEIGHT OF THE WARMER AND THAT THE UNIT SQUEAKED WHEN ADJUSTED. THE DISTRIBUTOR ADVISED THAT THE POLYSLEEVE PLASTIC ON A HEIGHT ADJUSTMENT SPRING WAS NOT PRESENT, WHICH WOULD HAVE CAUSED FRICTION AND SQUEAKING INSIDE OF THE ADJUSTMENT POLE. THE POLYSLEEVE PLASTIC COMES WITH A CAUTION LABEL WHICH READS "DO NOT REMOVE", HOWEVER IT IS POSSIBLE THAT THE SPRING WAS REMOVED FROM THE SLEEVE DURING ASSEMBLY OF THE UNIT BY THE HOSPITAL (B)(6). THE CUSTOMER HAS BEEN PROVIDED WITH A REPLACEMENT POLE ASSEMBLY, SPRING AND POLYSLEEVE FOR EACH OF THE SIX WARMERS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 090820 OR 090901.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4), LOT NUMBER: 090901, DATE OF MANUFACTURE: 09/01/2009. (B)(4), 090901, 09/01/2009. (B)(4), 090820, 08/20/2009. (B)(4), 090820, 08/20/2009. (B)(4), 090820, 08/20/2009. (B)(4), 090820, 08/20/2009. WE HAVE RECEIVED PHOTOGRAPHS AND FOLLOW-UP INFORMATION FROM THE CUSTOMER AND OUR EVALUATION IS STILL IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE POLE ASSEMBLY ON SIX IW910 INFANT WARMERS WAS NOT FIRMLY SECURED TO THE BASE. THE LOOSE POLES WERE OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE POLE ASSEMBLY ON SIX IW910 INFANT WARMERS WAS NOT FIRMLY SECURED TO THE BASE. THE LOOSE POLES WERE OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1