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

Device Problems Nonstandard Device (1420); Computer Operating System Problem (2898)

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

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on (b)(6) 2016.The recall classification number is (b)(4).Patient information could not be obtained due to country privacy laws.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 the unit rebooted during a case.There was no reported patient injury.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5808764
• MDR Text Key: 50770900
• Report Number: 2112667-2016-01366
• Device Sequence Number: 0
• Product Code: BSZ
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1