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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HEPA LIGHT WITHOUT PORT,CLEAN; FILTER, BACTERIAL, BREATHING CIRCUIT
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TELEFLEX MEDICAL HUDSON HEPA LIGHT WITHOUT PORT,CLEAN; FILTER, BACTERIAL, BREATHING CIRCUIT Back to Search Results
Catalog Number 28012
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been returned to the manufacturer.However, the investigation of said device is still in progress at the time of this report.
 
Event Description
Customer complaint alleges that "that the iso-gard hepa light filter was plugged solid".Alleged issue reported as detected just as the device was put to use.It was reported there was no injury or consequence to the patient.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the filter appeared dark and moist.This can happen due to the accumulation of condensation, secretions, or contamination after usage.The instructions for use (ifu) states to regularly monitor the patient's need for additional humidity, and to replace the filter every 24 hours or less, as required.At the manufacturing site, 100% drop testing is conducted; therefore, any blockages would be detected prior to release.Based on the visual inspection, the product was assembled correctly.In addition, 100% drop testing was conducted at the manufacturing facility.The reported failure may occur due to the accumulation of condensation or secretions after usage.A conclusion code could not be chosen as a root cause could not be established.
 
Event Description
Customer complaint alleges that "that the iso-gard hepa light filter was plugged solid".Alleged issue reported as detected just as the device was put to use.It was reported there was no injury or consequence to the patient.
 
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Brand Name
HUDSON HEPA LIGHT WITHOUT PORT,CLEAN
Type of Device
FILTER, BACTERIAL, BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL
po box 28, kamunting industrial estate
perak, west malaysia 34600
MY   34600
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6556754
MDR Text Key74830292
Report Number8040412-2017-00093
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Respiratory Therapist
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number28012
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
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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