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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2021
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. Date of device manufacture year is 2002. The month of manufacture was unavailable at time of mdr filing. The leak was from a detached inspiratory flow sensor. The customer replaced the unit. No repair information provided.
 
Event Description
The hospital reported a leak greater than 4. 5lpm causing a loss of all ventilation modes. There was no report of patient involvement.
 
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Brand NameAVANCE
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key11508762
MDR Text Key242497906
Report Number2112667-2021-00754
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
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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