BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL WALL MOUNT INFANT WARMER

    MDR report key: 2024549 · Received March 20, 2011

    Report

    Report Number
    9611451-2011-00173
    Event Type
    Malfunction
    Date Received
    March 20, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED IW980JEU INFANT WARMER UNITS ARE NOT EXPECTED TO BE RETURNED TO FPH FOR INSPECTION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE MEDICAL CENTER IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED FAULT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBERS: (B)(4), DEVICE MANUFACTURE DATES: 08/25/2003; (B)(4), 08/25/2003; (B)(4), 09/19/2003; (B)(4), 09/19/2003; (B)(4), 09/19/2003; (B)(4), 10/21/2004. METHOD: THE HARNESSES OF THE SIX IW980JEU BABY CONTROL WALL MOUNT INFANT WARMERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. OUR ANALYSIS IS BASED ON THE EVENT DESCRIPTIONS AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE MEDICAL CENTER IN (B)(6) REPORTED THAT THEIR SIX IW980JEU UNITS HAD DISCOLOURED UPPER AND LOWER HARNESS CONNECTORS. CONCLUSION: THE UPPER AND LOWER HARNESSES ARE USED TO CONNECT THE HEAD UNIT TO THE CONTROL UNIT OF THE INFANT WARMER. PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS REVEALED THAT THE DISCOLOURED HARNESS CONNECTORS OF THE INFANT WARMERS WERE MOST LIKELY DUE TO THE ARCING THAT OCCURRED BETWEEN TWO ELECTRICAL CONTACTS, RESULTING IN CONTACT FAILURE. THE ARCING WAS MOST LIKELY DUE TO A POOR CONNECTION. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY (B)(4). SHOULD THE CONNECTORS COMPLETELY FAIL DURING THE OPERATION, AN AUDIBLE AND VISUAL ALARM WILL BE REGISTERED ON THE FRONT CONTROL PANEL OF THE INFANT WARMER, THEREBY ALLOWING THE HOSPITAL STAFF TIME TO ACT AND PROVIDE OTHER MEANS OF WARMING. REPLACEMENT PARTS HAVE SINCE BEEN SENT TO THE MEDICAL CENTER TO REPLACE THE DISCOLOURED HARNESS CONNECTORS.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT SIX IW980JEU BABY CONTROL WALL MOUNT INFANT WARMERS HAD DISCOLOURED LOWER AND UPPER HEAD HARNESSES. THIS WAS OBSERVED AFTER PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT SIX IW980JEU BABY CONTROL WALL MOUNT INFANT WARMERS HAD DISCOLOURED LOWER AND UPPER HEAD HARNESSES. THIS WAS OBSERVED AFTER PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROL WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW980JEU

    Patients

    Seq Age Sex Outcome Treatment
    1