BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 4825702 · Received June 8, 2015

    Report

    Report Number
    9611451-2015-00274
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 11, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF REPORT WAS CHANGED FROM (B)(6) 2015 TO (B)(6) 2015. THE PRODUCT DESCRIPTION WAS CHANGED FROM MANUAL CONTROLLED COSYCOT INFANT WARMER TO BABY CONTROL COSYCOT INFANT WARMER. THE PRODUCT MODEL AND CATALOGUE NUMBER WERE CHANGED TO FROM IW950AEK TO IW932AEK. METHOD: THE COMPLAINT IW932AEK BABY CONTROL COSYCOT INFANT WARMER WAS SERVICED BY A QUALIFIED SERVICE ENGINEER OF FPH UK AT THE HOSPITAL'S FACILITY. OUR ANALYSIS IS BASED ON THE SERVICE REPORT AND PHOTOGRAPHS PROVIDED BY FPH SERVICE ENGINEER, AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: PHOTOGRAPHS PROVIDED BY FPH SERVICE ENGINEER REVEALED THAT THERE WERE LONGITUDINAL CRACKS AT THE CENTER OF THE COLUMN OF THE PLASTIC LEGS. THE REVIEW OF OUR PRODUCTION RECORD SHOWED THAT THERE WAS NO DISCREPANCY WITH THE SUBJECT INFANT WARMER WHEN IT WAS RELEASED FOR DISTRIBUTION MORE THAN 10 YEARS AGO. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 041116. CONCLUSION: CRACKS TO THE PLASTIC LEG BASE REGION OF THE COSYCOT INFANT WARMER ARE KNOWN TO OCCUR WHEN IT HAS BEEN OVERLOADED. THE MAXIMUM WEIGHT LIMIT FOR THE INFANT WARMERS IS SPECIFIED IN THE INFANT WARMER PRODUCT TECHNICAL MANUAL (PTM). NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. THE INFANT WARMER WAS RETURNED INTO HOSPITAL SERVICE AFTER THE PLASTIC BASE WAS REPLACED WITH A METAL BASE AND THE UNIT PASSED THE PERFORMANCE CHECKS SPECIFIED IN THE PTM. SERVICING CONDUCTED AT THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IW932AEK MANUAL CONTROLLED COSYCOT INFANT WARMER HAS ONLY RECENTLY BEEN SERVICED BY A QUALIFIED SERVICE ENGINEER FROM FISHER & PAYKEL HEALTHCARE SERVICE CENTRE IN THE (B)(6). 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 REPORTED EVENT. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE REAR LEGS OF AN IW932AEK MANUAL CONTROLLED COSYCOT INFANT WARMER WERE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED. THE HOSPITAL ALSO REQUESTED TO REPAIR THE UNIT.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE REAR LEGS OF AN IW932AEK BABY CONTROL COSYCOT INFANT WARMER WERE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED. THE HOSPITAL ALSO REQUESTED TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367974 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW932AEK

    Patients

    Seq Age Sex Outcome Treatment
    1