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

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

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 assembly was replaced to resolve the reported issue.No report of patient involvement.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported that the bag to vent switch was stuck and would not switch from mechanical to manual mode.

• Brand Name: CARESTATION 650
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 7082560
• MDR Text Key: 93767157
• Report Number: 2112667-2017-02280
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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