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 2017-09-05 for VOLDYNE 2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
[85109551]
(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 to the manufacturer at the time of this report. A device history record investigation did not show issues related to this complaint. Review of revision of (b)(4) rev 06 was performed and the failure mode is already included. No update is required. A sample of 13 devices were taken from the current production. The samples were functionally inspected. The issue reported "failure to function" was not observed. Customer complaint cannot be confirmed based on the information available at this time. No corrective actions can be assigned. If the device sample becomes available at a later date, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[85109552]
Customer complaint alleges that " at the patient's breathing exercise, the flow cup moved up but when falling down the cup got stuck". No report of patient harm or injury. No report of necessary medical intervention. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00967 |
| MDR Report Key | 6843109 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2017-09-05 |
| 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 | 2017-09-05 |
| Returned To Mfg | 2017-10-30 |
| 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 | 2017-09-05 |