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

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

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 mounting arm hardware was replaced to resolve the issue.

Event Description

The hospital reported the display mount is broken and the display fell off of the mounting arm.There was no report of patient involvement.

Manufacturer Narrative

Additional review of the event determined the event was not a 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: 11580886
• MDR Text Key: 243920006
• Report Number: 2112667-2021-00853
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1