CARESCAPE B450
Received Aug 22, 2025
Report 9610105-2025-00006 · MDR key 22872117
Device
Product problems
- Improper or Incorrect Procedure or Method
- Data Problem
- Improper or Incorrect Procedure or Method
- Data Problem
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510 A1-6: PATIENT INFORMATION CURRENTLY NOT AVAILABLE. B3: INCIDENT DATE UNKNOWN. GE HEALTHCARE'S INVESTIGATION IS IN-PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT'S MONITORING DATA WAS INADVERTENTLY COMBINED WITH ANOTHER PATIENT. THE PATIENT WAS MISDIAGNOSED AND WAS UNNECESSARILY TREATED WITH MEDICATION. THE PATIENT DID NOT SUSTAIN ANY INJURY DUE TO THE UNNECESSARY TREATMENT.
Additional Manufacturer Narrative
ON JULY 24, 2025, GE HEALTHCARE (GEHC) WAS NOTIFIED OF AN INCIDENT INVOLVING A CARESCAPE B450 V3 MONITOR WITH A PDM MODULE. THE CUSTOMER REPORTED THAT PATIENT DATA WAS COMBINED, LEADING TO A MISDIAGNOSIS AND INCORRECT MEDICATION ADMINISTRATION; HOWEVER, NO PATIENT HARM WAS REPORTED TO GEHC. GEHC REVIEWED ECG PRINTOUTS AND DEVICE LOGS, BUT THE CUSTOMER DECLINED TO PROVIDE FURTHER DETAILS. BASED ON AVAILABLE INFORMATION, IT APPEARS THAT ON (B)(6) 2025, THE USER INADVERTENTLY MERGED PDM DATA FROM BED 14 (PREVIOUS PATIENT) INTO BED 19 (NEW PATIENT) WHEN DOCKING THE PDM. THE LOGS SHOW THE PDM WAS DISCONNECTED FROM BED 14 AT 05:43 AND CONNECTED TO BED 19, WHERE LOAD FROM PDM WAS SELECTED AT 05:45, IMPORTING PRIOR PATIENT DATA. THE USER MANUAL ADVISES DISCHARGING PREVIOUS CASES BEFORE STARTING A NEW ONE TO PREVENT DATA CARRYOVER. THE INVESTIGATION CONCLUDED THE MONITOR OPERATED AS INTENDED, WITH NO DEVICE MALFUNCTION. GEHC CONCLUDED THAT NO FURTHER ACTION IS NECESSARY.