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

Device Problems Device Alarm System (1012); Human-Device Interface Problem (2949)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 11/10/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The reported event was caused by use error.The clinician did not confirm the agent setting after the vaporizer cassette was reinstalled in the machine after filling.Patient information could not be obtained after multiple attempts.Attempts were made as follows: (b)(6) 2016 via email , (b)(6) 2016 via phone, and (b)(6) via email.User filed medwatch (b)(4).The reported event was caused by use error.The clinician did not confirm the agent setting after the vaporizer cassette was reinstalled in the machine after filling.Patient information could not be obtained after multiple attempts.Attempts were made as follows: (b)(6) 2016 via email , (b)(6) 2016 via phone, and (b)(6) via email.(b)(4).

Event Description

Per the user filed medwatch report: "the vaporizer for the anesthesia machine was switched out during surgery.The alarm on the machine and the vaporizer shut off automatically after a short period of time.The process is reliant on human factors, i.E.The anesthesiologist to manually acknowledge and activate the vaporizer.Due to a distraction, anesthesia did not notice the vaporizer had shut off and there was no additional warning from the machine.Patient was not getting the agent necessary to maintain anesthesia and woke during the surgery." upon follow-up with the facility, it was reported that the patient moved and broke some stitches that had to be re-sutured.The facility further reported the patient incurred no injury and experienced no recall of the surgical event.

• 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: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5643666
• MDR Text Key: 44833124
• Report Number: 2112667-2016-00877
• 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,other,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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
• Date Manufacturer Received: 04/13/2016
• Date Device Manufactured: 06/18/2007
• 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