E-SCAIOVE
Received Dec 8, 2025 · Event occurred Nov 3, 2025
Report 9610105-2025-00009 · MDR key 23738770
Device
Generic name
Analyzer, Gas, Carbon-dioxide
Manufacturer
Ge Healthcare Finland OyProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
GE HEALTHCARE REVIEWED THE IMAGES PROVIDED OF THE AFFECTED MODULE, THE MODULE DESIGN, AND THE SERVICE MANUAL INSTRUCTIONS. THE INVESTIGATION CONCLUDED THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. HOWEVER, IT WAS NOTED THAT THE SERVICE MANUAL BEING USED AT THE TIME WAS NOT THE MOST RECENT AVAILABLE VERSION. GE HEALTHCARE IDENTIFIED A PROCESS IMPROVEMENT OPPORTUNITY IN THE DISTRIBUTION OF UPDATED SERVICE MANUALS AND ARE UNDERTAKING THE NECESSARY ACTIONS ADDRESS IT.
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510. A1-6: NOT AVAILABLE AT THIS TIME. D4: THE SERIAL NUMBER AND UDI WERE NOT PROVIDED. H4: NOT AVAILABLE BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS IN-PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE PERFORMING PLANNED MAINTENANCE, THE BIOMEDICAL ENGINEER SUSTAINED A LACERATION TO THEIR THUMB FROM A METAL PIECE UNDER THE FRONT COVER. THE LACERATION REQUIRED STITCHES.