MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-12 for VEEVO INTERMITTANT/CONTINUOUS 1500 SERIES TWSA1500 manufactured by Tenacore Holdings, Inc..
[51995617]
Patient Sequence No: 1, Text Type: N, H10
[51995618]
Biomed went to the surgical icu to investigate the continuous/intermittent suction regulators. Found the ohio medical and the ohmeda medical suction regulators to be working properly, but the tenacore suction regulators tested did not work in the intermittent mode. Biomed opened one of the broken tenacore suction regulators and found the rubber gasket was cracked causing the suction gauge to lose its intermittent function. Biomed checked all tenacore suction regulators in the whole medical center and found several with this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5871399 |
| MDR Report Key | 5871399 |
| Date Received | 2016-08-12 |
| Date of Report | 2016-07-05 |
| Date of Event | 2015-12-21 |
| Report Date | 2016-07-05 |
| Date Reported to FDA | 2016-07-05 |
| Date Reported to Mfgr | 2016-07-05 |
| Date Added to Maude | 2016-08-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEEVO INTERMITTANT/CONTINUOUS 1500 SERIES |
| Generic Name | REGULATOR, VACUUM - TENACORE VACUUM REGULATOR |
| Product Code | KDP |
| Date Received | 2016-08-12 |
| Model Number | TWSA1500 |
| Catalog Number | TWSA1500 |
| ID Number | TWSA-DM0DH-C |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENACORE HOLDINGS, INC. |
| Manufacturer Address | 1525 E EDINGER AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-12 |