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

Model Number 1011-9000-000

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The crossover hose was replaced to resolve the reported issue.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1011-9000-000 anesthesia gas machine experienced a damaged crossover hose resulting in a leak greater than 4.5l per minute.The report was received from a single source.The reported event did not involve a patient.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8793511
• MDR Text Key: 151322763
• Report Number: 2112667-2019-00302
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1011-9000-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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