BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL WALL MOUNT INFANT WARMER

    MDR report key: 3062080 · Received April 16, 2013

    Report

    Report Number
    9611451-2013-00278
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4); MANUFACTURING DATE: 03/23/2012, 03/23/2012, 03/23/2012, 03/26/2012, 03/26/2012. THE COMPLAINT DEVICES ARE NOT EXPECTED TO BE RETURNED TO FPH FOR INVESTIGATION. 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). SERIAL NUMBER: 120323000384, MANUFACTURING DATE: 03/23/2012; (B)(4), 03/23/2012; (B)(4), 03/23/2012; (B)(4), 03/26/2012; (B)(4), 03/26/2012. METHOD: THE COMPLAINT DEVICES WERE NOT RETURNED TO FPH FOR INVESTIGATION. THE INSTALLATION RECORD SHOWED THAT THE DEVICES WERE INSTALLED AT THE HOSPITAL IN NOVEMBER 2012. A REPLICATION TEST WAS CONDUCTED AT FPH (B)(4) TO CHECK IF THE PIVOT SECURING NUT WOULD BECOME COMPLETELY UNSCREWED IF THE WARMER HEAD WAS SWIVELLED 90 DEGREES FROM THE 'PARKED POSITION' OF THE HEAD IN A COSYCABINET TO THE CENTRE POSITION DURING USE . THE HEAD WAS SWIVELLED FOR A NUMBER OF CYCLES, APPROXIMATELY EIGHT USES PER DAY FOR A PERIOD OF 111 DAYS. THE 111 DAYS REPRESENTED THE ESTIMATED TIME THE UNITS HAVE BEEN IN SERVICE, BASED ON THE DATE THEY WERE INSTALLED AT THE HOSPITAL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE PRODUCTION AND INSTALLATION RECORDS, AND RESULTS OF THE REPLICATION TEST. RESULTS: NO DISCREPANCY WAS NOTED WITH THE PRODUCTION AND INSTALLATION RECORDS. THE INFANT WARMER UNITS WERE APPROXIMATELY 111 DAYS IN SERVICE AT THE HOSPITAL WHEN THE REPORTED FAULT WAS OBSERVED. THE REPLICATION TESTING REVEALED THAT THE PIVOT NUT SCREW DID NOT LOOSEN COMPLETELY WHEN IT WAS SWIVELLED 888 TIMES. THE SCREW WAS STILL HOLDING THE HEAD. IT REQUIRES MORE THAN FOUR FULL ROTATIONS TO COMPLETELY UNSCREW THE NUT; THE TEST RESULT SHOWED THAT THE MAXIMUM SHIFT IS LESS THAN HALF OF ONE FULL TURN. THOUGH THE PAIR OF WASHERS ENSURES THERE IS NO HORIZONTAL FRICTION AND TORQUE APPLIED TO THE NUT, IT DEVIATES IN POSITION DUE TO THE VERTICAL FORCE EXERTED ON THE NUT BY THE HEAD WEIGHT AND DISTURBS THE NUT TIGHTNESS; ALTHOUGH NOT ENOUGH TO COMPLETELY LOOSEN WITHIN THE APPROXIMATE TIME SPAN THE UNITS WERE IN USE. CONCLUSION: WE WERE UNABLE TO DETERMINE HOW THE SCREWS LOOSENED AS REPORTED BY THE HOSPITAL. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE RECEIVED WHERE THE HEAD NUT COMES LOOSE WHEN INSTALLED IN A COSYCABINET. WE HAVE BEEN INFORMED THAT THE PIVOT SECURING NUT ON THE FIVE INFANT WARMERS HAS BEEN GLUED TO THE SCREW BOSS AT THE ADVICE OF OUR FPH SERVICE MANAGER IN THE (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) TERRITORY MANAGER THAT THE HEATER HEAD OF FIVE IW980AEK BABY CONTROL WALL MOUNT INFANT WARMERS HAD LOOSE CONNECTION ON THE COSYCABINET. THIS WAS OBSERVED BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) TERRITORY MANAGER THAT THE PIVOT NUT WAS COMING LOOSE ON FIVE IW980AEK BABY CONTROL WALL MOUNT INFANT WARMERS. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163582 BABY CONTROL WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW980AEK

    Patients

    Seq Age Sex Outcome Treatment
    1