BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREPLUS

    MDR report key: 17929724 · Received October 13, 2023

    Report

    Report Number
    1121732-2023-00001
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 13, 2023
    Report Date
    February 23, 2024
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K213551
    Removal / Correction Number
    GEHC RECALL #32093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS (GEHC) INVESTIGATION HAS BEEN COMPLETED. INSPECTION OF THE UNIT BY THE END USER CONFIRMED THERE WAS NO ISSUE RELATED TO THE FUNCTION OF THE INCUBATOR. BASED ON THE REPORTED INFORMATION, THE MOTHER OF THE PATIENT PROBABLY CLOSED THE DOOR BUT WAS UNSURE IF THE DOOR WAS LATCHED CORRECTLY. THE PROBABLE ROOT CAUSE OF THE PATIENT FALL IS USE ERROR AND INADEQUATE WARNING LABEL ON THE UNIT. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION TO ADDRESS THE PRODUCT LABELING ISSUE PER 21 CFR 806 ON 05-JAN-2024. THE GE HEALTHCARE RECALL NUMBER IS 32093. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND PROVIDES ACTIONS TO BE TAKEN BY THE CUSTOMER FOR THE CONTINUED USE OF THE DEVICE. GE HEALTHCARE WILL PROVIDE A USER MANUAL ADDENDUM AND LABEL TO CORRECT THE ISSUE.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A1, A3, A5, AND A6: NO INFORMATION PROVIDED. LEGAL MANUFACTURER: HCS LAUREL - 8880 GORMAN RD USA LAUREL, MD 20723 H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED TO GE HEALTHCARE (GEHC) THAT A PATIENT FELL FROM A CAREPLUS INFANT WARMER. THE PATIENT RECEIVED A CT SCAN AND NEURO VITAL SIGNS WERE TAKEN AFTER THE INCIDENT WHICH DID NOT IDENTIFY ANY INJURY. GEHC WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552391 CAREPLUS WARMER, INFANT RADIANT FMZ OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Unknown Other