MalfunctionCAD
TEC 7
Received Nov 27, 2024 · Event occurred Oct 31, 2024
Report 2112667-2024-06383 · MDR key 20801370
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Product code (CAD)
Manufacturer (Datex-ohmeda, Inc.)
Model (VAP SEVO 8%)
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
VAP SEVO 8%Catalog number
NA
Lot number
NA
Product problems
- Output below Specifications
- No Apparent Adverse Event
- Output below Specifications
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAN -20% OF SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
BLOCK D4: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.