BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 10935421 · Received December 2, 2020

    Report

    Report Number
    2112667-2020-03347
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 2, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K122267
    Removal / Correction Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 20 MARCH 2019. THE FDA RECALL NUMBER IS Z-1846-2019 & Z-1847-2019. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO INSPECT THE WARMER BEDSIDE PANEL LATCH AREAS. REPLACEMENT OF BROKEN BEDSIDE PANELS WILL BE PROVIDED BY GEHC. A SET OF WARNING LABELS WILL BE SUPPLIED FOR APPLICATION TO THE BEDSIDE PANELS. THESE LABELS WILL WARN THE USER TO NOT USE THE BEDSIDE PANELS FOR MANEUVERING THE WARMER AND INDICATE THE CORRECT METHOD OF MANEUVERING THE WARMER. AN ADDENDUM TO THE OPERATION AND MAINTENANCE MANUAL WILL ALSO BE PROVIDED EMPHASIZING THE NEED TO CHECK AND ENSURE THAT THE BEDSIDE PANELS AND LATCHES ARE NOT CRACKED, BROKEN, OR DAMAGED BEFORE EVERY PATIENT USE. THE ADDENDUM WILL ALSO CONTAIN INSTRUCTIONS TO INCREASE DETECTABILITY OF BROKEN OR CRACKED BEDSIDE PANELS. ON JUNE 14, 2019 A LETTER WAS SENT TO CUSTOMERS PROVIDING AN ADDITIONAL ADDENDUM, LABELS, AND WALL POSTER. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 20 MARCH 2019. THE FDA RECALL NUMBER IS Z-1846-2019 & Z-1847-2019.

    Description of Event or Problem · 1

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL Z-1846-2019 & Z-1847-2019, THIS SYSTEM WAS IDENTIFIED AS HAVING THE BROKEN LATCH AND/OR CRACKED WALL MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397779 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1