MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Model Number 1011-9050-000

Device Problem Gas/Air Leak (2946)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a large leak preventing mechanical ventilation.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the leak was less than 4.5lpm.A preop check of the machine, as contained in the user manual, will pick up such a condition.As stated in the report, the preop test failed, notifying the user of the reported condition.The leak may be able to be compensated for or made up with fresh gas flow.H3 other text: additional information was received that the leak was less than 4.5lpm.A preop check of the machine, as contained in the user manual, will pick up such a condition.As stated in the report, the preop test failed, notifying the user of the reported condition.The leak may be able to be compensated for or made up with fresh gas flow.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11812423
• MDR Text Key: 252919575
• Report Number: 2112667-2021-01230
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• 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: 05/17/2021

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: 1011-9050-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1