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 2019-02-12 for VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.
[136048132]
Qn# (b)(4). The customer returned one unit 8884719009 voldyne 5000 volumetric exerciser for investigation. The returned breathing exerciser was visually examined and no defects or anomalies were observed. The returned volumetric exerciser was able to pass a functional inspection when connected to a vacuumed air. The piston and yellow flow cup were both able to move freely within the device. A device history record review was performed on the received sample lot number 73j1800456, with no evidence of a manufacturing related issue found. The reported complaint of "yellow float sticks during use" was not confirmed based upon the sample received. There were no functional issues found with the returned sample. A corrective action is not required at this time as there were no functional issues found with the returned sample. (continued). Other remarks: the ifu for this product, l06121, was reviewed as a part of this complaint investigation. The ifu instructs the end user, "exhale normally. Then place lips tightly around mouthpiece. Inhale slowly to raise the white piston in the chamber. Inhale slowly to raise the piston in the chamber. When inhaling, maintain top of the yellow flow cup in the 'best' flow range. " "continue inhaling and try to raise piston to prescribed level. " telefelex will continue to monitor customer feedback for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[136048133]
Customer complaint states: "rt reported that the yellow float on the left side is sticking. " no patient harm reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-00079 |
| MDR Report Key | 8330827 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-12 |
| Date of Report | 2019-01-16 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-02-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VOLDYNE 5000 VOLUMETRIC EXERCISER |
| Generic Name | SPIROMETER, THERAPEUTIC (INCEN |
| Product Code | BWF |
| Date Received | 2019-02-12 |
| Returned To Mfg | 2019-01-23 |
| Catalog Number | 8884719009 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| 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 | 2019-02-12 |