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

Catalog Number 8884719009

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received for evaluation by the manufacturer at the time of this report.Verification of failure mode reported in the current manufacturing process was conducted.Thirteen devices were taken from the current production, and functionally inspected.The issue reported was not observed in the current manufacturing process.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 determinate 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 with the evaluation results.

Event Description

Customer complaint alleges the piston in the cylinder is not moving during patient use.It was reported no patient injury occurred.Patient condition was reported as "fine".

Event Description

Customer complaint alleges the piston in the cylinder is not moving during patient use.It was reported no patient injury occurred.Patient condition was reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint of "piston in cylinder not moving in use" was not confirmed based upon the sample received.The returned volumetric exerciser was able to pass a functional inspection when connected to a vacuumed air.The piston was able to move freely within the device.There were no functional issues found with the returned sample.A corrective action is not required at this time as there were no functional issues found with the returned sample.Teleflex will continue to monitor customer feedback for complaints of this nature.

• Brand Name: HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7731388
• MDR Text Key: 115389510
• Report Number: 3003898360-2018-00598
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• PMA/PMN Number: K801199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8884719009
• Device Lot Number: 73H1700667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.