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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7900 ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Crack (1135); Suction Failure (4039)
Patient Problem No Patient Involvement (2645)
Event Date 06/24/2020
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. A ge healthcare service representative performed a checkout of the system with the hospital biomed remotely and confirmed the reported issue. The suction regulator was replaced to resolve the reported issue.

 
Event Description

The hospital reported a malfunction of the suction regulator causing a loss of suction. There was no report of patient involvement.

 
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Brand NameAESTIVA 7900
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key10303251
MDR Text Key202051832
Report Number2112667-2020-02073
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/22/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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