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

Model Number	IPN049316
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part # 8884719009 is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 samples were taken from the current production part # 8884719025 voldyne2500 volumetric exerciser, lot# 73j2100616, the samples were functionally inspected, and during the test issue reported "leak - plastic housing" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number of the device was not provided.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 "when the user attempted to use the device, air leaked from the main body.Therefore, a new unit was used instead".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 8884719009 voldyne 5000 volumetric exerciser for investigation.The sample was shipped to medline for investigation.The investigation results are as follows: "medline.Quality received a quality complaint for 1 ea of 88847149009 (hud719009).The lot number was 73c2000354.It was reported that when the user attempted to use the device, air leaked from the main body.Therefore, a new unit was used instead.We did receive a sample of the complaint.The sample was in good condition with no visible cracks.The only visible issue with the unit was the paper on the bottom of the unit.The paper was not making a complete seal around the base.There was a visible "hump" in the middle of the paper which could be pushed down with a finger.You could also see a gap between the paper and the bottom of the unit when looking through the one of the 3 cutouts at the bottom when the unit is turned upside down." "while testing the unit, the only air that could be detected was coming from the rectangular cutouts at the base of the unit.As a result, we are unable to confirm the reported complaint with the sample.We will notify the manufacturer of the issue on a quarterly basis.The division will monitor the complaint during quarterly trending.".
Event or Problem Description
It was reported "when the user attempted to use the device, air leaked from the main body.Therefore, a new unit was used instead".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: VOLDYNE 5000 VOLUMETRIC EXERCISER
• Common Device Name: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12646899
• Report Number: 3003898360-2021-00938
• Device Sequence Number: 1295687
• Product Code: BWF
• UDI-Device Identifier: 14026704630179
• UDI-Public: 14026704630179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K801199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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
• Device Model Number: IPN049316
• Device Catalogue Number: 8884719009
• Device Lot Number: 73C2000354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown