MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-05-12 for HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
[45071748]
Qn#(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. A device history record review could not be conducted since the lot number was not provided. A document assessment (fmea) was conducted and no changes required. Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause. If the device sample becomes available at a later date, this complaint will be updated accordingly. Teleflex will continue to be monitoring trending on similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[45071749]
The customer alleges that the disc on the right hand side (tube) of the device will no longer go up. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2016-00508 |
| MDR Report Key | 5651344 |
| Report Source | CONSUMER |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-05-12 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 VOLDYNE2500 VOLUMETRIC EXERCISER |
| Generic Name | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2016-05-12 |
| Catalog Number | 8884719025 |
| Lot Number | UNKNOWN |
| 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 | 2016-05-12 |