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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE
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TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE Back to Search Results
Catalog Number 425-00
Device Problem Temperature Problem (3022)
Patient Problem Erythema (1840)
Event Date 02/11/2015
Event Type  malfunction  
Event Description
The customer alleges that the unit got hot and the infant's skin had red marks.The biomed states that the respiratory therapist indicated that the infant may have been lying on the circuit.
 
Manufacturer Narrative
(b)(4).The user facility (b)(6) states that the respiratory therapist indicated that the infant may have been lying on the circuit.The infant was re-positioned and the red marks went away.The device was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record investigation did not show issues related to complaint.The device was manufactured on (b)(6) 2011.A document assessment (fmea) was conducted and no changes were required.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate, b.c. 2147 8 MX
MX   21478 MX
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4602841
MDR Text Key5466373
Report Number3003898360-2015-00147
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/11/2015
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 Number425-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2015
Initial Date FDA Received03/09/2015
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 Unknown
Patient Sequence Number1
Treatment
CIRCUIT
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