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 MEDICAL VOLDYNE 2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN
  • 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 MEDICAL VOLDYNE 2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN Back to Search Results
Catalog Number 8884719025
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional, and dimensional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.Six devices were taken from the current production, the samples were functionally inspected, and during the test issue reported "flow cup does not move during use" was not observed in the current manufacturing process.A device history record investigation did not show issues related to this complaint.Customer complaint cannot be confirmed based on the information provided and current findings.It is necessary to receive the physical sample involved to perform a proper investigation and confirm the alleged defect reported.If the device sample becomes available at a later date, this report will be updated accordingly.
 
Event Description
Customer complaint alleges "at the patient's breathing exercise, the flow cup didn't move up".Alleged malfunction reported as occurred during use.Patient condition reported as "fine".It was reported there was no necessary medical intervention.
 
Manufacturer Narrative
(b)(4).The sample was returned for investigation.The returned breathing exerciser was visually examined and no defects or anomalies were observed.A functional inspection was performed on the returned breathing exerciser to simulate use.The exerciser was connected to a vacuum flowmeter to test for movement of the piston inside the device.Upon functional inspection, it was found that the piston was able to freely move up and down the device.No functional issues were found.The instructions for use (ifu) for this product instructs the end user, "exhale normally.Then place lips tightly around mouthpiece.Inhale slowly to raise the white piston in the chamber.When inhaling, maintain top of the yellow flow cup in the 'best' flow range." "continue inhaling and try to raise piston to prescribed level." the reported complaint of "flow cup does not move during use" was not confirmed based upon the sample received.The returned breathing exerciser was able to pass a functional inspection when connected to vacuumed air.The piston was able to move freely within the device.A device history record review was performed on the device with no evidence of a manufacturing related issue found.There were no functional issues found with the returned sample.
 
Event Description
Customer complaint alleges "at the patient's breathing exercise, the flow cup didn't move up".Alleged malfunction reported as occurred during use.Patient condition reported as "fine".It was reported there was no necessary medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VOLDYNE 2500 VOLUMETRIC EXERCISER
Type of Device
SPIROMETER, THERAPEUTIC (INCEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6889963
MDR Text Key87205007
Report Number3003898360-2017-00998
Device Sequence Number1
Product Code BWF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K801199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number8884719025
Device Lot Number73A1700767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-