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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. H-V FILTER SMALL ANGLED, STERILE; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL SDN. BHD. H-V FILTER SMALL ANGLED, STERILE; CONDENSER, HEAT AND MOISTURE Back to Search Results
Catalog Number G18501
Device Problem Break (1069)
Patient Problem Unspecified Respiratory Problem (4464)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported "when a leak test was performed on artificial respiration on the anesthesia machine before the filter was attached to the patient, there was no problem.Then, the patient was anesthetized, repositioned to the prone position, and operated on.After about 1 hour, a respiratory / monitor alarm went off.The user immediately switched to ambu bag and found that the filter was broken.No injury to the patient occurred as the filter was immediately replaced with a new one".Patient condition reported as "fine".
 
Event Description
It was reported "when a leak test was performed on artificial respiration on the anesthesia machine before the filter was attached to the patient, there was no problem.Then, the patient was anesthetized, repositioned to the prone position, and operated on.After about 1 hour, a respiratory / monitor alarm went off.The user immediately switched to ambu bag and found that the filter was broken.No injury to the patient occurred as the filter was immediately replaced with a new one".Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the filter was broken.It was reported that the sample was broken during use on the patient.There was no issue found prior to use.The manufacturer reports that in the current manufacturing procedure, 100% leak testing during the assembly process and 100% visual inspection at the packing area is conducted; thus , any defective products will be detected prior to release from the manufacturing facility.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed, however, a root cause could not be identified.The breakage may be due to high force applied on the device or mishandling by the user, although this could not be confirmed.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
H-V FILTER SMALL ANGLED, STERILE
Type of Device
CONDENSER, HEAT AND MOISTURE
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key11836740
MDR Text Key268679834
Report Number8040412-2021-00136
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberG18501
Device Lot NumberKMH20K0457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2021
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANESTHESIA MACHINE; ANESTHESIA MACHINE
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