MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2016

Event Type  malfunction  

Manufacturer Narrative

A gehc service representative performed a checkout of the equipment and confirmed the reported complaint.The breathing circuit was replaced.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 noted that, following cleaning of the breathing circuit, it was cracked, creating a leak condition.There was no report of patient involvement.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6255684
• MDR Text Key: 64904749
• Report Number: 2112667-2017-00133
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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