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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPTUNE
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TELEFLEX HUDSON CONCHA NEPTUNE Back to Search Results
Catalog Number 425-00
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2014
Event Type  malfunction  
Event Description
The event is reported as: the display/touch pad is not working.No report of pt injury or safety issues related to a pt.
 
Manufacturer Narrative
Product usage when alleged defect was encountered is unk.The device sample was received by the mfr, but the investigation is incomplete at the time of this report.Per dhr (device history record) the product concha neptune, serial # (b)(4) was manufactured on 06/02/2008.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Manufacturer (Section D)
TELEFLEX
rtp NC
Manufacturer (Section G)
TELEFLEX MEDICAL
prolongacion mision eusebio
kino # 1316,rancho el descanso
tecate, b.c.
MX  
Manufacturer Contact
margie burton, rn, ra
po box 12600
durham, NC 27709
9194334965
MDR Report Key4095590
MDR Text Key21879721
Report Number3003898360-2014-00699
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 Not Applicable
Type of Report Initial
Report Date 08/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2014
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 Manufacturer08/26/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2008
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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