MAUDE Adverse Event Report: TELEFLEX MEDICAL VOLDYNE 2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN

Catalog Number 8884719025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned to the manufacturer at the time of this report.A device history record investigation did not show issues related to this complaint.Review of revision of (b)(4) rev 06 was performed and the failure mode is already included.No update is required.A sample of 13 devices were taken from the current production.The samples were functionally inspected.The issue reported "failure to function" was not observed.Customer complaint cannot be confirmed based on the information available at this time.No corrective actions can be assigned.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges that " at the patient's breathing exercise, the flow cup moved up but when falling down the cup got stuck".No report of patient harm or injury.No report of necessary medical intervention.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one unit 8884719025 voldyne2500 volumetric exerciser for investigation.The returned breathing exerciser was visually examined and it was found that a piece of the piston was bent out of place.No other 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 the device.However, the piston would occasionally get stuck around the 500ml mark on its way down.The sample was shipped to the manufacturing site for further investigation.Upon investigation, it was found that the device worked properly.It could not be determined what initially caused the piston to occasionally get stuck around the 500ml mark.Although the piston had a piece bent out of place, it could not be confirmed whether or not this was the cause of the complaint issue.Other remarks: the instructions for use (ifu) for this product was reviewed as a part of this complaint investigation.The ifu 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 sticks during use" was confirmed based upon the sample received.Functional inspection of the device revealed that the piston would occasionally get stuck around the 500ml mark on its way down.However, the sample was shipped to the manufacturing site and further testing showed that the device worked properly.The device was returned with a piece of the piston bent out of place but it could not be confirmed whether or not it could cause the piston to get stuck in the device.A device history record review was performed on the device with no evidence to suggest a manufacturing related issue.The root cause of this complaint is undetermined as it could not be determined what caused the piston to get stuck during the initial functional inspection.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges that " at the patient's breathing exercise, the flow cup moved up but when falling down the cup got stuck".No report of patient harm or injury.No report of necessary medical intervention.Patient condition reported as "fine".

• 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 Key: 6843109
• MDR Text Key: 85109551
• Report Number: 3003898360-2017-00967
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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: 73A1700767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1