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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
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. Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.
 
Event Description
The hospital reported a malfunction causing a leak greater than 4. 5 lpm. There was no report of patient involvement.
 
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Brand NameAESTIVA 7100
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3030 ohmeda drive
madison, WI 53718
MDR Report Key12092112
MDR Text Key261900545
Report Number2112667-2021-01647
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
Report Date 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
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 Received07/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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