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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE Back to Search Results
Model Number IPN041365
Device Problems Complete Blockage (1094); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use on a patient, the "teleflex filter had occluded at the sample port due to a thin plastic disc (presumably left over from the manufacturing process) which has then blocked gas from entering the sample line, therefore did not display c02/sevo etc.Values/waveforms on the anesthetic machine".No patient harm, desaturation, or injury."the ventilation was not affected as it was the co2 sampling port that was blocked, not the main ventilating body.The issue was resolved by changing the filter.The initial filter was then inspected and the co2 port was found to blocked by what appeared to be plastic from the manufacturing process.".
 
Event Description
It was reported that during use on a patient, the "teleflex filter had occluded at the sample port due to a thin plastic disc (presumably left over from the manufacturing process) which has then blocked gas from entering the sample line, therefore did not display c02/sevo etc.Values/waveforms on the anesthetic machine".No patient harm, desaturation, or injury."the ventilation was not affected as it was the co2 sampling port that was blocked, not the main ventilating body.The issue was resolved by changing the filter.The initial filter was then inspected and the co2 port was found to blocked by what appeared to be plastic from the manufacturing process.".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The manufacturing site reports "checking the history of this reported defect, occluded co2 port, there is similar complaint reported for similar product code which is 11012t.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) has been issued, root cause analysis and identified corrective actions shall be implemented through this scar".Without the actual 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.
 
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Brand Name
HUMID VENT PEDI
Type of Device
CONDENSER, HEAT AND MOISTURE
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL SDN. BHD.
lot no : pt2577 jalen perusahaan
4 kamunting industrial estate
perak, west malaysia 34600
MY   34600
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17913118
MDR Text Key325402219
Report Number8040412-2023-00366
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/25/2023
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
Device Model NumberIPN041365
Device Catalogue Number11012T
Device Lot NumberKMZ23A0453
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/11/2023
Supplement Dates Manufacturer Received11/10/2023
Supplement Dates FDA Received11/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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