• 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 VIEW 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 VIEW ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9212-000
Device Problem Pressure Problem
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Patient identifier information could not be obtained. Unique device identifier: (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Device evaluation anticipated, but not yet begun.

 
Event Description

'the hospital reported a patient had cardiac arrest during a case. It was alleged the ventilator had stopped mechanically ventilating in pressure mode towards the end of the case without alarming. It was unknown how long ventilation had stopped. The patient was resuscitated and remains in the icu.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESPIRE VIEW
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 Key8319602
Report Number2112667-2019-00011
Device Sequence Number1
Product CodeBSZ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 05/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1009-9212-000
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2019
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

Patient TREATMENT DATA
Date Received: 02/08/2019 Patient Sequence Number: 1
-
-