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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 6 PLUS; VAPORIZER

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DATEX-OHMEDA, INC. TEC 6 PLUS; VAPORIZER Back to Search Results
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Event Description
It was reported that there was a malfunction resulting in agent delivery of less than 20% of setting.There was no patient involvement.
 
Manufacturer Narrative
Ge healthcareâ¿¿s 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.
 
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Brand Name
TEC 6 PLUS
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 Key18756858
MDR Text Key335985877
Report Number2112667-2024-00974
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K000275
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 04/10/2024
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 01/24/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received04/10/2024
Supplement Dates FDA Received04/10/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/16/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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