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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); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2020
Event Type  Malfunction  
Manufacturer Narrative

The distributor performed a checkout of the equipment and confirmed the reported complaint. A proposal to replace the holder and cover flow assembly. To date, the proposal has not been accepted. No further information is available regarding the resolution of the reported 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.

 
Event Description

The hospital reported an alarm caused by a cracked holder and cover flow sensor resulting in a loss of mechanical ventilation. 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 Key9708622
MDR Text Key201198825
Report Number2112667-2020-00443
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 DISTRIBUTOR,FOREIGN,HEALTH PR
Type of Report Initial
Report Date 02/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2020
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 Received01/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/26/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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