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..
[5112006]
At different occasions from (b)(6) 2014 the (b)(6) facility reported that the master stations of the nurse call system were not annunciating calls from some stations, and this did not generate a 'fault' condition. During this period of time many attempts were made to insure the system did not go into this mode. All attempts would work for a period of time before the system would again become non-responsive. At different points in time, new product, (patient stations, control modules, and master stations) were sent to the facility and the allegedly defective product returned to us for further testing. Our goal was to replicate the problem in our lab to help us find a solution. To date, though we've provided a solution, we have not been able to replicate the problem in house. A factory site visit was made on 06/25/2014. Unfortunately our technician was not able to observe the conditions described above. As a precaution and to help us further diagnose the problem, all control modules were replaced, the installation was checked, and some minor changes were made. On 08/05/2014 the facility reported that the problem has reoccurred. We returned to the site on 08/08/2014 to replace all central equipment including the cabinets, and to put in place supervisory hardware and diagnostic software to help us diagnose and fix the problem. The diagnostic hardware also served to provide external supervision in the event the system became unresponsive. With the help of date gleaned from the diagnostic tools placed on-site we were able to locate the portion of code that could cause the problem. The updated version of software was installed on the system 09/17/2014. To date the problem has not re-occurred. After verifying that the system at shelby has not gone into an unresponsive mode, on 10/01/2014 we released a 'critical software update' notice to our tektone elite partners, (teps) who are responsible for the sale and installation of the tc400 nurse call systems. This was done via e-mail and the notice was posted on tep website. They were given until november 1st to update the code at the facilities. During that month and email was reminder was sent out 5 times. On november 10th we sent certified notices to all facilities who had not received the update. We will continue to follow up with the facilities until all have facilities receive the software update. Of all the facilities that have had our nurse call system installed since 2008 only shelby nursing facility has exhibited the behavior described above. (we believe one other site may have had a similar problem, but were not able to confirm). This represents 0. 5% of installed systems. There have not been any reports of injuries or death.
Patient Sequence No: 1, Text Type: D, B5
[12677863]
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 shelby. 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. Analysis: it took tektone an inordinate amount of time to discover and remedy the problem. Although analysis of the call logs reveals a constant exchange of information, and resultant actions since the problem was first reported, (hindsight being 20/20), our placement of analytical software and supervisory hardware on 08/14/2014 could've been sooner. Of course had we been able to duplicate the problem in our lab we certainly would have acted. Corrective action - customer complaints: as of 11/19/2014 we've added the fda sop#17 "handling of customer complaints for medical device products" to our iso: 2000-9001 quality system. Sop# 17 has a lower threshold for determining whether or not a technical support call should be elevated to a complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001757821-2014-00001 |
| MDR Report Key | 4369909 |
| Report Source | 07 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-02-24 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2015-01-15 |
| 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 28737 |
| Manufacturer Country | US |
| Manufacturer Postal | 28737 |
| 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 Age | DA |
| 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 |