• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATEX-OHMEDA, INC. AESPIRE 7900 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem No Device Output (1435)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2017
Event Type  Malfunction  
Manufacturer Narrative

A gehc service representative performed a checkout of the equipment and confirmed the mylar flap of the flow sensors was stuck to the top of the flow sensor housing. The flow sensors were replaced, and the unit was returned to service. 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 problems with flow measurement. There was no report of patient involvement.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESPIRE 7900
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6331750
MDR Text Key67496923
Report Number2112667-2017-00310
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK050626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 02/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2017
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 Received01/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/03/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-