• 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 7100 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 7100 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-8003-000
Device Problem Loss of Power (1475)
Patient Problem No Patient Involvement (2645)
Event Date 11/29/2018
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 manufacture was not available at the time of filing. Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the unit would unexpectedly shutdown. There was no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The control board was replaced, and the unit was returned to service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESPIRE 7100
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 Key8203926
MDR Text Key131903922
Report Number2112667-2018-02578
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K000706
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 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1009-8003-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-