BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE R860

    MDR report key: 16702448 · Received April 7, 2023

    Report

    Report Number
    9710602-2023-00342
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 7, 2023
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Removal / Correction Number
    Z-1226-2022, Z-1227-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS BATTERY ISSUE PER 21 CFR 806 ON 21-APR-2022. THE FDA RECALL NUMBER IS Z-1226-2022, Z-1227-2022. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO PERFORM THE BATTERY PERFORMANCE TEST TO DETERMINE IF THEIR BATTERIES MAY BE IMPACTED. GEHC WILL PROVIDE BATTERY REPLACEMENTS, UPDATED USER MANUAL FOR BATTERY CAPACITY TESTING, BATTERY PREVENTATIVE REPLACEMENT FREQUENCY, AND POTENTIALLY NEW SOFTWARE BASED ON THE PRODUCT MODEL. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. BLOCK UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE DURING INSPECTION THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442217 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown