Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN; BREATHING CIRCUIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN; BREATHING CIRCUIT Back to Search Results
Catalog Number 780-07
Device Problems Device Dislodged or Dislocated (2923); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the inspiratory wire appears to have slipped a large distance from the area of the temperature probe and the circuit is not heating.No report of pt injury or harm.
 
Manufacturer Narrative
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.The customer complaint cannot be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.If the defective sample becomes available at a later date this complaint will be re-opened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
rtp NC
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key4062889
MDR Text Key4850307
Report Number3004365956-2014-00334
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 08/05/2014
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 Number780-07
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/05/2014
Initial Date FDA Received08/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-