MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-25 for VOLDYNE 2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
[87205007]
(b)(4). A visual, functional, and dimensional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report. Six devices were taken from the current production, the samples were functionally inspected, and during the test issue reported "flow cup does not move during use" 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 based on the information provided and current findings. It is necessary to receive the physical sample involved to perform a proper investigation and confirm the alleged defect reported. If the device sample becomes available at a later date, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[87205008]
Customer complaint alleges "at the patient's breathing exercise, the flow cup didn't move up". Alleged malfunction reported as occurred during use. Patient condition reported as "fine". It was reported there was no necessary medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00998 |
| MDR Report Key | 6889963 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2018-01-23 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2017-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOLDYNE 2500 VOLUMETRIC EXERCISER |
| Generic Name | SPIROMETER, THERAPEUTIC (INCEN |
| Product Code | BWF |
| Date Received | 2017-09-25 |
| Returned To Mfg | 2017-11-16 |
| Catalog Number | 8884719025 |
| Lot Number | 73A1700767 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-25 |