MAUDE Adverse Event Report: TELEFLEX MEDICAL VOLDYNE 5000 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN

Catalog Number 8884719009

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.A verification of failure mode reported in the current manufacturing process was conducted as follows: 25 devices were taken from the current production, 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

Patient called and reported using the device after being hospitalized for pneumonia.Patient reported the device stopped working after a few days.The yellow peg does not move when trying to use the device.No patient harm reported.

• Brand Name: VOLDYNE 5000 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10502210
• MDR Text Key: 206806422
• Report Number: 3003898360-2020-00722
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8884719009
• Device Lot Number: 73D2000298
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1