MAUDE Adverse Event Report: TELEFLEX MEDICAL VOLDYNE2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN

Catalog Number 8884719025

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 35 devices were taken from the current production p/n 8884719025 voldyne2500 volumetric exerciser lot # 73j1900496, the samples were functionally inspected, and during the test the issue reported was not observed in the current manufacturing process.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer complaint alleges the yellow peg is getting stuck during use.No report of patient injury or consequence.Additional information was requested, but not available at the time of this report.

Manufacturer Narrative

(b)(4).The customer returned one unit 8884719025 voldyne2500 volumetric exerciser 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 flow cup and piston inside the device.Upon functional inspection, it was found that the flow cup and piston were both able to freely move up and down the device.No functional issues were found.The 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." a device history record review was performed and no relevant findings were identified.The reported complaint of "yellow peg sticks during use" was not confirmed based upon the sample received.The returned volumetric exerciser was able to pass a functional inspection when connected to a vacuumed air.The flow cup and piston were both 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 the yellow peg is getting stuck during use.No report of patient injury or consequence.Additional information was requested, but not available at the time of this report.

• Brand Name: VOLDYNE2500 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9163809
• MDR Text Key: 169865010
• Report Number: 3003898360-2019-01180
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8884719025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.