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

Device Problem High Readings (2459)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Pt info not provided due to country privacy laws.(b)(4).Initial reporter address: not provided due to country privacy laws.Legal manufacturer: (b)(4).Ge healthcare's investigation is on-going at this time.A follow-up report will be submitted when the investigation is completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that incorrectly high invasive arterial blood pressures were provided for which the patient was administered antihypertensive medication.

Manufacturer Narrative

Investigation findings: the customer reported that the carescape one provided incorrectly high arterial blood pressures when compared to the noninvasive blood pressure (nibp) readings.This issue resulted in the patient receiving unnecessary antihypertensive medication.The patient did not sustain any injury due to the alleged unnecessary treatment.The device was not returned to ge healthcare (gehc) for testing.However, the device log files and arterial line waveform printouts were provided for analysis which did not show any indication of malfunction.In a review of historical data, gehc did not identify any adverse trend related to the reported issue.Gehc's investigation concluded that the device was operating as specified.

• Brand Name: CARESCAPE ONE
• Type of Device: 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 ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 16210449
• MDR Text Key: 307766368
• Report Number: 9610105-2023-00001
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K200494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention