MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER; INCENTIVE SPIROMETER

Catalog Number 8884719025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device was reprocessed per product complaint form.A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record investigation did not show issues related to complaint.A document 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.At this time since the device sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

The customer alleges that the exerciser didn't show any reaction to the patient's breath.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.A functional inspection was performed by connecting the returned exerciser to vacuum air.Upon connection, the flow cup and piston began to rise immediately.No functional defects were detected.The reported complaint that the exerciser had no response to breath was not confirmed based upon the sample received.The returned exerciser functioned as intended while connected to vacuum air.However, it should be noted that the ifu for this product indicates "inhale slowly to raise the white piston in the chamber." exhaling will not move the internal parts.A dhr review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned sample.

Event Description

The customer alleges that the exerciser didn't show any reaction to the patient's breath.No patient injury reported.

• Brand Name: HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER
• Type of Device: INCENTIVE SPIROMETER
• 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: 5897460
• MDR Text Key: 52837162
• Report Number: 3003898360-2016-00826
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8884719025
• Device Lot Number: 73F1500193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1