MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-26 for HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.
[101020794]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned. Verification of failure mode reported in the current manufacturing process was conducted as follows: thirteen (13) devices were taken from the current production. The samples were functionally inspected, and during the test, the issue reported was not observed in the current manufacturing process. A device history record investigation did not show issues related to this complaint. It is necessary to receive the physical sample to perform a proper investigation to confirm the alleged defect, determine a root cause and any corresponding corrective actions. Customer reports the device was discarded. Customer complaint cannot be confirmed. Root cause cannot be determined. Corrective actions cannot be established. If the sample becomes available at a later date, this report will be updated accordingly. Teleflex will continue to monitor and trend for this and similar complaints for this device.
Patient Sequence No: 1, Text Type: N, H10
[101020795]
Customer complaint alleges "the device was working fine but for the last two weeks it hasn't been working. " customer reports the ball not moving. Alleged malfunction reported occurring during use. No report of patient harm or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-00090 |
| MDR Report Key | 7297045 |
| Report Source | CONSUMER |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-12 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2017-09-05 |
| Date Added to Maude | 2018-02-26 |
| 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 (INCEN |
| Product Code | BWF |
| Date Received | 2018-02-26 |
| Catalog Number | 8884719009 |
| Lot Number | 73J1700055 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-02-26 |