FDA.reportPublic FDA data

MAUDE MDR 4369890

MDR report key
4369890
Report number
3001757821-2014-00002
Event key
0
Event type
3
Date of event
2014-09-11
Date received
2014-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
277 INDUSTRIAL PARK RD. FRANKLIN NC 28734 US
Phone
828-828-8285
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEKTONENURSE CALL SYSTEMTEKTONE SOUND & SIGNAL MANUFACTURING, INC.IQATC400, TC400P5R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-210

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.