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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CO2 SOFTECH CANNULA A, 14FT 14FT, M; ANALYZER, GAS, CARBON-DIOXIDE,
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TELEFLEX MEDICAL HUDSON CO2 SOFTECH CANNULA A, 14FT 14FT, M; ANALYZER, GAS, CARBON-DIOXIDE, Back to Search Results
Catalog Number 2848
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer complaint reported as: collapsing and cannot get a patient reading.Additional information was requested, but was not available at the time of this report.Issue for collapsing captured in 3011137372-2020-00138.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer complaint reported as: collapsing and cannot get a patient reading.Additional information was requested, but was not available at the time of this report.Issue for collapsing captured in 3011137372-2020-00138.
 
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Brand Name
HUDSON CO2 SOFTECH CANNULA A, 14FT 14FT, M
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE,
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10191805
MDR Text Key202402112
Report Number3011137372-2020-00139
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K143469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number2848
Device Lot Number191089
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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