MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 620; ANESTHESIA GAS MACHINE

Model Number 1012-9620-000

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The bag/vent switch module was disassembled.All mechanical parts were lubricated to resolve the reported issue.No report of patient involvement.(b)(4).

Event Description

The hospital reported that the bag/vent switch stuck and could not moved from bag to vent mode intermittently.There was no report of patient involvement.

• Brand Name: CARESTATION 620
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7348426
• MDR Text Key: 102733395
• Report Number: 2112667-2018-00586
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-9620-000
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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