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

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained after multiple attempts.Attempts were made as follows: on (b)(6) 2015, voicemail, (b)(6) 2015 - phone, (b)(6) 2015 - email.Ge healthcare has recommended to the hospital to replace the display flashcard and download new software.Patient information could not be obtained after multiple attempts.Attempts were made as follows: on (b)(6) 2015, voicemail, (b)(6) 2015 - phone, (b)(6) 2015 - email.Ge healthcare has recommended to the hospital to replace the display flashcard and download new software.

Event Description

The hospital reported that, during a case, the unit shut down.The clinician reportedly swapped out the anesthesia machine.There was no reported patient injury.

• Brand Name: AISYS
• 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: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 5320020
• MDR Text Key: 34162635
• Report Number: 2112667-2015-00449
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/22/2015
• Date Device Manufactured: 06/11/2010
• 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