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

Model Number	IPN049316
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted, and 13 devices were taken from the current production (p/n 8884719009 voldyne 5000 volumetric exerciser lot # 73c2100527) at the manufacturing facility.The devices were functionally inspected, and issue reported " piston not moving properly" was not observed in the current manufacturing process.A device history record review was performed and no relevant findings were identified.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 or Problem Description
It was reported "ball is not moving when patient breathes".Unknown patient condition at time of report.No patient harm reported.

• Brand Name: VOLDYNE 5000 VOLUMETRIC EXERCISER
• Common Device Name: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11613299
• Report Number: 3003898360-2021-00316
• Device Sequence Number: 11553511
• Product Code: BWF
• UDI-Device Identifier: 14026704630179
• UDI-Public: 14026704630179
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K801199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IPN049316
• Device Catalogue Number: 8884719009
• Device Lot Number: 73B2000053
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.