MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1; ANESTHESIA GAS MACHINE

Model Number 1012-9650-000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Serial numbers: (b)(4).For 2 of the 3 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported event.The co2 bypass assembly was replaced to resolve the issue for 2 units.For 1 of the reported events, a ge healthcare service representative performed a checkout of the system and did not confirm the reported event.

Event Description

This report summarizes 3 malfunction events.A review of the events indicated that model 1012-9650-000 anesthesia gas machine experienced unexpected therapeutic results.1 event was reported for increased fico2 readings during ventilation requiring an increased flow of fresh gas, 1 event was reported for a malfunction resulting in elevated co2 levels in the patient circuit, 1 event was reported for elevated co2 readings during inspiration causing potential hypoxic mixture to the patient.These reports were received from various sources.Of the 3 events, 1 did not involve a patient, and 2 did involve patients.There is no patient information available.

• Brand Name: CARESTATION 650 A1
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8532029
• MDR Text Key: 145656485
• Report Number: 9710602-2019-00008
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682103947
• UDI-Public: 010084068210394721
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1012-9650-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1