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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HEAT AND MOISTURE EXCHANGER WITH FILTER GIBECK; Filter, bacterial, breathing-circuit
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TELEFLEX MEDICAL SDN. BHD. HEAT AND MOISTURE EXCHANGER WITH FILTER GIBECK; Filter, bacterial, breathing-circuit Back to Search Results
Catalog Number MEDICAL UNKNOWN
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
It was reported that an "antibacterial filter with missing cap" was found "during pretest, not during use on patient".Further information states, "the initial test machine not in use; failure found during the initial test pass the call to the field" and that "a loss of more than 4.5; l / min.Mechanical and manual ventilation not possible.Removed the filter".Multiple attempts to reach out to the customer for further information were made with no response.If additional information is received on this complaint, the file will be updated.
 
Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
Qn# (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.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that an "antibacterial filter with missing cap" was found "during pretest, not during use on patient".Further information states, "the initial test machine not in use; failure found during the initial test pass the call to the field" and that "a loss of more than 4.5; l / min.Mechanical and manual ventilation not possible.Removed the filter".Multiple attempts to reach out to the customer for further information were made with no response.If additional information is received on this complaint, the file will be updated.
 
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Brand Name
HEAT AND MOISTURE EXCHANGER WITH FILTER GIBECK
Type of Device
Filter, bacterial, breathing-circuit
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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key15880217
MDR Text Key304475222
Report Number8040412-2022-00335
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Reporter Country CodeIT
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 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMEDICAL UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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