MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER; SPIROMETER, THERAPEUTIC (INCEN

Catalog Number 8884719025

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not bee received by the manufacturer for evaluation at the time of this report.A device history record investigation did not show issues related to this complaint.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges the yellow indicator peg sticks during use.Reported by a home care user.Customer states the device must be shaken to reset the peg.No harm was reported.Patient condition reported as "fine".

• Brand Name: HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• 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: 7753134
• MDR Text Key: 116122201
• Report Number: 3003898360-2018-00623
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• 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: 73L1700257
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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