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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET, LONG LENGTH; BREATHING CIRCUIT
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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET, LONG LENGTH; BREATHING CIRCUIT Back to Search Results
Catalog Number 1607
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the inspiratory limb of the circuit is disconnecting from the ventilator.The pt condition is reported as fine.
 
Manufacturer Narrative
A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number (b)(4) was 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.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause.In order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If defective sample becomes available at a later date this complaint will be reopened.
 
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Brand Name
HUDSON VENTILATOR TUBING SET, LONG LENGTH
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3938088
MDR Text Key21489974
Report Number3004365956-2014-00117
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1607
Device Lot Number02F1300572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
VENTILATOR
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