BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE R860

    MDR report key: 15386029 · Received September 8, 2022

    Report

    Report Number
    9710602-2022-00547
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Report Date
    October 5, 2022
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Removal / Correction Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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. NO REPORT OF PATIENT INVOLVEMENT. UNIQUE IDENTIFIER: (B)(4). THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: (B)(4). GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPORT OF PATIENT INVOLVEMENT. UNIQUE IDENTIFIER: (B)(4). THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 04 MAY 2022. THE FDA RECALL NUMBERS ARE Z-1285-2022 AND Z-1286-2022. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO PERFORM THE BATTERY PERFORMANCE TEST. REPLACEMENT OF THE BATTERIES WILL BE PROVIDED BY GEHC.

    Description of Event or Problem · 0

    DURING DEVICE TESTING, A BATTERY FAILURE WHICH COULD RESULT IN A LOSS OF MECHANICAL VENTILATION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320106 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown