MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-10 for HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.
[74812086]
(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 at the time of this report. A device history record investigation did not show issues related to this complaint. A record assessment (fmea) was conducted and no changes required. Customer complaint cannot be confirmed based on the information received. Corrective actions cannot be established at his time. To perform a proper investigation, it is necessary to have the device sample to confirm the alleged defect, and determine a root cause. If the device sample becomes available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[74812087]
Home care customer complaint alleges that the "ball does not move when blowing inside" the device. Alleged malfunction reported as occurring during use. No report of injury or complication. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00559 |
| MDR Report Key | 6556560 |
| Report Source | CONSUMER |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-29 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-04-29 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2017-05-10 |
| 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 | 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 (INCENTIVE) |
| Product Code | BWF |
| Date Received | 2017-05-10 |
| Catalog Number | 8884719009 |
| Lot Number | 73A1700044 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-10 |