ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) FREQUENTLY DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES, REQUIRING FREQUENT RESTARTS OF THE MULTIPLE PATIENT RECEIVER (ORG) TO KEEP IT RUNNING. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) FREQUENTLY DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES, REQUIRING FREQUENT RESTARTS OF THE MULTIPLE PATIENT RECEIVER (ORG) TO KEEP IT RUNNING. RESETTING AND REBOOTING THE ORG HAS BEEN A TEMPORARY FIX BUT THEY WANT TO SEND IN THE ORG FOR REPAIR. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE REPORTED DEVICE WAS SENT TO NKA FOR EVALUATION AND REPAIR. DURING EVALUATION, THE REPORTED ISSUE WAS DUPLICATED, AND THE CAUSE WAS ATTRIBUTED TO A FAULTY UR-3981 CPU BOARD. THE MALFUNCTIONING COMPONENT WAS REPLACED, AND THE UNIT PERFORMED TO MANUFACTURER'S SPECIFICATIONS AFTER THE REPAIR. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO SIMILAR ISSUES. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: 5 ZM TRANSMITTERS: MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 01/07/2021, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT, G3 DATE RECEIVED BY MANUFACTURER, G6 TYPE OF REPORT, H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES, H11 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) FREQUENTLY DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES, REQUIRING FREQUENT RESTARTS OF THE MULTIPLE PATIENT RECEIVER (ORG) TO KEEP IT RUNNING. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) FREQUENTLY DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES, REQUIRING FREQUENT RESTARTS OF THE MULTIPLE PATIENT RECEIVER (ORG) TO KEEP IT RUNNING. RESETTING AND REBOOTING THE ORG HAS BEEN A TEMPORARY FIX BUT THEY WANT TO SEND IN THE ORG FOR REPAIR. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: 5 ZM TRANSMITTERS: MODEL#: ZM-531PA, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 01/07/2021, UNIQUE IDENTIFIER (UDI)#: (B)(4), RETURNED TO NIHON KOHDEN: NA.