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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET, LONG LENGTH; ADULT CONVENTIONAL CIRCUIT
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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET, LONG LENGTH; ADULT CONVENTIONAL CIRCUIT Back to Search Results
Catalog Number 1613
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Anxiety (2328); No Code Available (3191)
Event Date 04/24/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the device was in use on an adult als patient for life support.While turning the patient over in bed, the orderly and nursing staff inadvertently dislodged the blue cap which covers the temp probe which was not being utilized in this setup.The ventilator alarmed(leak alarm).The nursing staff put their finger over the open port until rt arrived to determine what happened."the patient was not harmed, but the reporter of this complaint stated the patient was clearly rattled as the breathing pressure was obviously falling." it should be noted that the original circuit was repaired and the hospital continued to use it on the als patient.
 
Manufacturer Narrative
Device available for evaluation: the user facility indicates that a sample will be returned, but it is a representative sample.A sample was returned to the manufacturer, but the results of the investigation are incomplete at the time of this report.The device history record (dhr) of batch number 02m1300844 has been reviewed and no issues or discrepancies were found related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.
 
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Brand Name
HUDSON VENTILATOR TUBING SET, LONG LENGTH
Type of Device
ADULT CONVENTIONAL CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3988034
MDR Text Key4749382
Report Number3004365956-2014-00194
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1613
Device Lot Number02M1300844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
VENTILATOR
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