• 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. TEC 850; VAPORIZER

  • 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. TEC 850; VAPORIZER Back to Search Results
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2023
Event Type  malfunction  
Event Description
It was reported that there was a malfunction resulting in agent delivery less than -20% of the setting.There was no patient involvement.
 
Manufacturer Narrative
Ge healthcare has investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: no report of patient involvement.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.H3 other text : device evaluation anticipated, but not yet begun.
 
Manufacturer Narrative
The customer declined ge service.No repair information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TEC 850
Type of Device
VAPORIZER
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key18586029
MDR Text Key333777287
Report Number2112667-2024-00526
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/26/2024
Supplement Dates Manufacturer Received03/15/2024
Supplement Dates FDA Received03/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
-
-