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 2016-08-23 for HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
[52837162]
(b)(4). It is unknown if the device was reprocessed per product complaint form. A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record investigation did not show issues related to complaint. A document assessment (fmea) was conducted and no changes required. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time since the device sample is not available, it is not possible to determine the source of the defect reported. 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.
Patient Sequence No: 1, Text Type: N, H10
[52837163]
The customer alleges that the exerciser didn't show any reaction to the patient's breath. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[56363102]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. A functional inspection was performed by connecting the returned exerciser to vacuum air. Upon connection, the flow cup and piston began to rise immediately. No functional defects were detected. The reported complaint that the exerciser had no response to breath was not confirmed based upon the sample received. The returned exerciser functioned as intended while connected to vacuum air. However, it should be noted that the ifu for this product indicates "inhale slowly to raise the white piston in the chamber. " exhaling will not move the internal parts. A dhr review was performed on the device with no evidence to suggest a manufacturing related cause. There were no functional issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[56363103]
The customer alleges that the exerciser didn't show any reaction to the patient's breath. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2016-00826 |
| MDR Report Key | 5897460 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2016-08-23 |
| 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 | HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER |
| Generic Name | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2016-08-23 |
| Returned To Mfg | 2016-08-29 |
| Catalog Number | 8884719025 |
| Lot Number | 73F1500193 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-08-23 |