MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650 A1; ANESTHESIA GAS MACHINE

Model Number 1012-9650-000

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, the customer biomedical engineer troubleshot the issue with ge healthcare technical support.It was recommended to replace the middle drawer assembly.The correct part number was provided.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1012-9650-000 anesthesia gas machine experienced threaded inserts stripped out in the middle drawer which could cause the drawer to the report was received from a single source.The reported event did not involve a patient.

• Brand Name: CARESTATION 650 A1
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8532475
• MDR Text Key: 144847882
• Report Number: 2112667-2019-00159
• 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): N
• 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

• Date FDA Received: 04/19/2019
• 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
• Date Manufacturer Received: 04/01/2019
• 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