MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER; SPIROMETER, THERAPUETIC

Catalog Number 8884717301

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect, and determine a root cause.Customer complaint cannot be confirmed.Root cause is unknown.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

Customer complaint alleges that "during use, the ball (or "the balls") in cylinder didn't move properly.Therefore, a new unit was used instead".No patient harm reported.Patient's condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.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 inner balls.All three inner balls were able to move within the breathing exerciser at a pressure that was within the acceptable tolerance for each ball.No functional issues were found.The instructions for use (ifu) for this product were reviewed as a part of this complaint investigation.The ifu instructs the end user, "inhale at a sufficient rate to raise only the ball in the first chamber, while the ball in the second chamber remains at rest.For a higher flow rate, inhale at a rate sufficient to raise the first and second balls, while the ball in the third chamber remains at rest." other remarks: the reported complaint of "balls stuck in cylinder" was not confirmed based upon the sample received.The returned breathing exerciser was able to pass a functional inspection when connected to a vacuumed air.All three inner balls were able to move within the breathing exerciser when the flowmeter was set to a pressure within the acceptable tolerance of each ball.There were no functional issues found with the returned sample.

Event Description

Customer complaint alleges that "during use, the ball (or "the balls") in cylinder didn't move properly.Therefore, a new unit was used instead".No patient harm reported.Patient's condition reported as "fine".

• Brand Name: HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER
• Type of Device: SPIROMETER, THERAPUETIC
• 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: 6387148
• MDR Text Key: 69365402
• Report Number: 3003898360-2017-00178
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8884717301
• Device Lot Number: 73F1600455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1