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

Model Number 1012-9650-000

Device Problems Inappropriate or Unexpected Reset (2959); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.To resolve the reported issue, the central processing unit was replaced.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1012-9650-000 anesthesia gas machine experienced a system reset error resulting in the loss of mechanical ventilation.This report was received from a single source.The reported event did involve a patient.

Manufacturer Narrative

Correction to block h1: the initial summary report submitted july 18, 2019 incorrectly indicated death in block h1.This supplemental correction is being submitted to correct the report type to malfunction.

• 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
• MDR Report Key: 8804168
• MDR Text Key: 151498135
• Report Number: 9710602-2019-00023
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682103947
• UDI-Public: 010084068210394721
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1