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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER
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TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER Back to Search Results
Catalog Number 5705
Device Problems Insufficient Heating (1287); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "the unit will come on and heat up, but its not providing the "continuous heated aerosol for cpap therapy breathing treatments.It did work when they received it, but this past weekend it just stopped working and the power light doesn't come on anymore." alleged issue detected during use.There was no report of patient impact or consequence.
 
Manufacturer Narrative
(b)(4).The sample was returned and forwarded to the manufacturer (pegasus) for evaluation.The manufacturer reports that upon receipt of unit the claim was not confirmed.The power switch did not illuminate when turned on, but unit did generate heat.Evaluation revealed that heater's power switch lamp was at fault.The component was inspected and did not present any visible defect, and the dhr shows that the heater was operable and within specifications at the time of release.This is a random component failure, which is not often seen in these units, especially at this age (223 days approximately).The power switch was replaced and the heater was retested as per procedure and found to meet specifications.The unit was repaired and returned.
 
Event Description
Customer complaint alleges "the unit will come on and heat up, but its not providing the "continuous heated aerosol for cpap therapy breathing treatments.It did work when they received it, but this past weekend it just stopped working and the power light doesn't come on anymore." alleged issue detected during use.There was no report of patient impact or consequence.
 
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Brand Name
HUDSON THERMAGARD NEBULIZER HEATER
Type of Device
BREATHING SYSTEM HEATER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7369919
MDR Text Key103531906
Report Number3011137372-2018-00087
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5705
Device Lot NumberSN:21925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received04/19/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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