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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANCE CS2 ANESTHESIA GAS MACHINE

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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 09/07/2021
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). Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Legal manufacturer: hcs madison - (b)(4). Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported a malfunction causing a leak in excess of 4. 5 lpm. There was no report of patient involvement.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
MDR Report Key12582998
MDR Text Key276387245
Report Number2112667-2021-02254
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
847-971-1
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
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 Received10/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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