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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON VENTILATOR TUBING SET, LONG LENGTH; ADULT BREATHING CIRCUIT
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TELEFLEX HUDSON VENTILATOR TUBING SET, LONG LENGTH; ADULT BREATHING CIRCUIT Back to Search Results
Catalog Number 1607
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the adult conventional ventilator circuit failed the est test as a result of a leak.The issue was detected prior to pt use.
 
Manufacturer Narrative
A device history record (dhr) review was performed and there were no issues found that would relate to the reported complaint.No non-conformance reports were originated for the lot in question.The product was assembled and inspected according to specs.The sample was returned for eval, however, the investigation was incomplete at the time of this report.A f/u report will be submitted with investigation results.
 
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Brand Name
HUDSON VENTILATOR TUBING SET, LONG LENGTH
Type of Device
ADULT BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
katharine tarpley
po box 12600
rtp, NC 27709
9194334854
MDR Report Key3994412
MDR Text Key4823752
Report Number3004365956-2014-00261
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/09/2014
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 Other
Device Catalogue Number1607
Device Lot Number74D1400362
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/14/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/09/2014
Initial Date FDA Received07/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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