• 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. AISYS 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. AISYS ANESTHESIA GAS MACHINE Back to Search Results
Device Problem No Flow (2991)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 12/18/2015
Event Type  Malfunction  
Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and a review of the logs. The anesthesia control board and the anesthesia delivery board were replaced, and the unit was returned to service. Patient information could not be obtained due to country privacy laws. 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 the unit alarmed for a vaporizer failure during a case. Agent delivery reportedly stopped and a change in the patient's blood pressure was noted. The clinician reportedly switched to propofol to continue the case. There was no reported patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAISYS
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 60010
MDR Report Key5369399
MDR Text Key36064089
Report Number2112667-2016-00071
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK042154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 01/15/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2016
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 Received12/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/15/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-