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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; ELECTRONIC THERMOMETER

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TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; ELECTRONIC THERMOMETER Back to Search Results
Catalog Number 395-90
Device Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record review could not be conducted since the serial number provided ((b)(4)) is not a valid serial number.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the device sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.
 
Event Description
The customer alleges that the heater continuously alarmed and the therapist tried to troubleshoot the problem.The probe was replaced and the issue was resolved.
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed on the lot number of the unit - (b)(4).There were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and no defects were observed.An electrical verification was conducted in order to check the conductivity on the unit.The sample was tested in different units and no issues were found.In addition, the sample was tested by 2 hours on a unit and worked properly.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
The customer alleges that the heater continuously alarmed and the therapist tried to troubleshoot the problem.The probe was replaced and the issue was resolved.
 
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Brand Name
HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A
Type of Device
ELECTRONIC THERMOMETER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5990633
MDR Text Key56042401
Report Number3003898360-2016-00917
Device Sequence Number1
Product Code FLL
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 09/20/2016
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 Catalogue Number395-90
Device Lot Number73A1600652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2016
Initial Date FDA Received09/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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