MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-24 for HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.
[26639829]
(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. 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 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. Teleflex will continue to monitor and trend on similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[26639830]
The customer alleges that the device is leaking during treatment. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[30123161]
(b)(4). The customer did not return the actual complaint sample, however, they did return three samples of the same lot number. A visual exam was performed on the units and no defects were observed. A functional test was performed on the returned units using a vacuum line. Each unit was connected to a vacuum line and immediately, both the white inner piston and the yellow inner flow cap moved. The units were confirmed to function properly. Based on the investigation performed, the reported complaint could not be confirmed. There were no issues found with the returned devices.
Patient Sequence No: 1, Text Type: N, H10
[30123162]
The customer alleges that the device is leaking during treatment. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2015-00667 |
| MDR Report Key | 5100719 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-14 |
| Date of Event | 2015-09-14 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2015-04-13 |
| Date Added to Maude | 2015-09-24 |
| 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 | RESPIRATORY THERAPIST |
| 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 VOLDYNE 5000 VOLUMETRIC EXERCISER |
| Generic Name | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2015-09-24 |
| Returned To Mfg | 2015-09-21 |
| Catalog Number | 8884719009 |
| Lot Number | 73D1500192 |
| 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 | 2015-09-24 |