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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 11/21/2022

Event Type  Injury  

Event Description

It was reported that incorrectly low invasive blood pressures were provided for which the patient was unnecessarily treated.

Manufacturer Narrative

Legal manufacturer: (b)(4).Initial reporter: the information was not available due to country privacy laws.Date of event: not provided, follow-up with customer is in-progress.Udi: (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.

Manufacturer Narrative

Ge healthcare (gehc) was informed that a patient was unnecessarily treated with medication based on incorrectly low invasive blood pressure readings provided by the gehc device.The patient did not sustain an injury due to the alleged unnecessary treatment.The customer provided the affected monitor, acquisition module, accessory cables along with blood pressure data for analysis.Gehc engineering analyzed the provided data and performed extensive device testing but could not identify any issue with the invasive blood pressure parameter.The devices passed testing.In a review of historical data, no adverse trend was identified with respect to the ibp function.Gehc's investigation concluded that the root cause could not be determined as the reported issue could not be reproduced.The service team continues to engage with the customer and provide additional training as needed.

• 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: 16029437
• MDR Text Key: 305977348
• Report Number: 9610105-2022-00009
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K190008
• 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: 02/10/2023

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?: Yes
• 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: 11/25/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other