MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-21 for TEKTONE TC400, TC400P5 manufactured by Tektone Sound & Signal Manufacturing, Inc..
[5112003]
On (b)(6) 2014, (b)(6) reported that the master stations of the nurse call system were annunciating calls from some stations, and this did not generate a 'fault' condition. An updated version of software was installed on the system (b)(6) 2014. To date the problem has not re-occurred.
Patient Sequence No: 1, Text Type: D, B5
[12677435]
Root cause: we believe a counting semaphore in the tc400 code caused the central equipment to stop polling. We determined this from the data received from our diagnostics tools on-site. Corrective action: we determined through testing that the counting semaphore is no longer needed and removed it from the system firmware. Validation: because we've not been able to duplicate the problem in house, we placed the code on-site at (b)(6). To date the original problem has not re-occurred. Preventive action: we added 'polling fault' code to the os software. This will alert the user should the nurse call system again become unresponsive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001757821-2014-00002 |
| MDR Report Key | 4369890 |
| Report Source | 07 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-11 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2015-01-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 277 INDUSTRIAL PARK RD. |
| Manufacturer City | FRANKLIN NC 28734 |
| Manufacturer Country | US |
| Manufacturer Postal | 28734 |
| Manufacturer Phone | 8285244013 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEKTONE |
| Generic Name | NURSE CALL SYSTEM |
| Product Code | IQA |
| Date Received | 2014-11-21 |
| Model Number | TC400, TC400P5 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEKTONE SOUND & SIGNAL MANUFACTURING, INC. |
| Manufacturer Address | 277 INDUSTRIAL PARK RD. FRANKLIN NC 28734 US 28734 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |