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

MAUDE Adverse Event Report: AVANCE 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
 

AVANCE CS2 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The absorber canister was replaced to resolve the issue. 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). Legal manufacturer: (b)(4).
 
Event Description
The hospital reported a large leak preventing mechanical ventilation. There was no report of patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
MDR Report Key12632098
MDR Text Key278814311
Report Number2112667-2021-02299
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-