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 2018-07-30 for HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.
[115389510]
(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.
Patient Sequence No: 1, Text Type: N, H10
[115389511]
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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-00598 |
| MDR Report Key | 7731388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2017-08-23 |
| Date Added to Maude | 2018-07-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 | HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER |
| Generic Name | SPIROMETER, THERAPEUTIC (INCEN |
| Product Code | BWF |
| Date Received | 2018-07-30 |
| Returned To Mfg | 2018-08-16 |
| Catalog Number | 8884719009 |
| Lot Number | 73H1700667 |
| 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 | 2018-07-30 |