• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATEX-OHMEDA, INC. AISYS CS2 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1011-9050-000
Device Problem Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Unique identifier: (b)(4). A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. Reconnected the exhaust hose from the gas module to the recycle savaging system to resolve the issue.
 
Event Description
The hospital reported a malfunction causing a leak in excess of 4. 5 lpm. There was no report of patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAISYS CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3030 ohmeda drive
madison, WI 
MDR Report Key11359487
MDR Text Key234271420
Report Number2112667-2021-00481
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1011-9050-000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-