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

Catalog Number 8884719009

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in this 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.Customer complaint cannot be confirmed based on the information received.Corrective actions cannot be established at his time.To perform a proper investigation, it is necessary to have the device sample to confirm the alleged defect, and determine a root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

Home care customer complaint alleges that the "ball does not move when blowing inside" the device.Alleged malfunction reported as occurring during use.No report of injury or complication.Patient condition reported as "fine".

• Brand Name: HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6556560
• MDR Text Key: 74812086
• Report Number: 3003898360-2017-00559
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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: 73A1700044
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1