MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY CARESCAPE B450; MONITOR, PHYSIOLOGICAL, PATIENT

Model Number	MBA313
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Data Problem (3196)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: CARESCAPE B450
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki FIN-0 0510; FI FIN-00510
• Manufacturer Contact: kristof soos ; 3114 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 22872117
• Report Number: 9610105-2025-00006
• Device Sequence Number: 20284469
• Product Code: MHX
• UDI-Device Identifier: 00840682142380
• UDI-Public: (01)00840682142380(11)190516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MBA313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown