MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-06 for TOFM manufactured by Tenacore Holdings, Inc..
[27557387]
Patient Sequence No: 1, Text Type: N, H10
[27557388]
This is more of a chronic failure not specific to a patient or one device. The flow meters that we have gotten from tenacore seem to have a weak inner tube where the flow ball indicator resides. The top of this tube constantly breaks into small pieces which could compromise the flow indicator. Manufacturer response for o2 flow meter, flow meter (per site reporter): they are working with their distributor to make this device better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5129680 |
| MDR Report Key | 5129680 |
| Date Received | 2015-10-06 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-29 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Generic Name | OXYGEN FLOW METER |
| Product Code | CAX |
| Date Received | 2015-10-06 |
| Model Number | TOFM |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENACORE HOLDINGS, INC. |
| Manufacturer Address | 1525 EAST EDINGER AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-06 |