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

Model Number 1011-9000-000

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The drawer and drawer assembly were replaced to resolve the issue.

Event Description

The hospital reported the bottom drawer fell off the unit.There was no report of patient involvement.

Manufacturer Narrative

Additional review of the event determined the event would be noted during pre-use testing as contained in the user manual and was not hazard that could lead to death or serious injury.There was no malfunction and no death or serious injury.The unit will continue to ventilate and alarms remain functional.The initial event was not a reportable malfunction.H3 other text : additional review of the event determined the event would be noted during pre-use testing as contained in the user manual and was not hazard that could lead to death or serious injury.There was no malfunction and no death or serious injury.The unit will continue to ventilate and alarms remain functional.The initial event was not a reportable malfunction.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11554571
• MDR Text Key: 243601012
• Report Number: 2112667-2021-00809
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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
• Device Model Number: 1011-9000-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1