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 VOLDYNE 5000 VOLUMETRIC EXERCISER; INCENTIVE SPIROMETER
  • 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 VOLDYNE 5000 VOLUMETRIC EXERCISER; INCENTIVE SPIROMETER Back to Search Results
Catalog Number 8884719009
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2014
Event Type  malfunction  
Event Description
The event is reported as: the device is not working and is causing the air to escape from the device.No patient injury reported.
 
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.Per dhr (device history record) the product voldyne 5000 volumetric exerciser, lot #01g1300344 was manufactured on 07/29/2013.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.The complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.Teleflex will continue to monitor and trend relating complaints.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER
Type of Device
INCENTIVE SPIROMETER
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3938105
MDR Text Key21530743
Report Number3003898360-2014-00129
Device Sequence Number1
Product Code BWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/11/2014
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 Lay User/Patient
Device Catalogue Number8884719009
Device Lot Number01G1300344
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-