MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 620 A1; ANESTHESIA GAS MACHINE

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The bag to vent switch was disassembled.Medical grease was added to the switch movement rod to resolve the reported issue.(b)(4).

Event Description

The hospital reported that the bag to vent switch is stuck, not moving from bag to vent.There was no report of patient involvement.

• Brand Name: CARESTATION 620 A1
• 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: 7320136
• MDR Text Key: 101966833
• Report Number: 2112667-2018-00481
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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