ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT EVEN AFTER COMING BACK FROM REPAIR THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING ISSUES WITH INTERMITTENT COMMUNICATION LOSS ON ALL INSTALLED RECEIVERS SIMULTANEOUSLY WHICH LASTS ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG-9110A, SN: (B)(6) WAS GETTING INTERMITTENT COMMUNICATION LOSS AFTER COMING BACK FROM REPAIR. AN EXCHANGE UNIT WAS SENT TO THE CUSTOMER, AND THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE WAS DUPLICATED, AND THE UNIT'S UR-3981 CPU BOARD WAS REPLACED. THE UNIT PERFORMED TO MANUFACTURER'S SPECIFICATIONS AFTER COMPONENT REPLACEMENT. THE UNIT HAD PREVIOUSLY BEEN RETURNED FOR INTERMITTENT COMMUNICATION LOSS IN TICKET (B)(4). THE COMPLAINT WAS NOT DUPLICATED DURING A 72-HOUR TEST PERIOD DUE TO THE SPORADIC NATURE OF THE MALFUNCTION. THE UNIT WAS RETURNED TO THE CUSTOMER WITHOUT CORRECTIVE ACTION, GIVING RISE TO THE CURRENT TICKET. THE ISSUE WAS RESOLVED BY PROVIDING THE CUSTOMER WITH A REFURBISHED EXCHANGE AND REPLACING THE CPU BOARD OF THE COMPLAINT DEVICE. CENTRAL NURSE'S STATION MODEL: PU-681RA SN: NI. TELEMETRY TRANSMITTER(S) MODEL: ZM-531PA SN: NI. TELEMETRY TRANSMITTER(S) MODEL: ZM-541PA SN: NI. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT D9 DEVICE AVAILABLE FOR EVALUATION G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT EVEN AFTER COMING BACK FROM REPAIR THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING ISSUES WITH INTERMITTENT COMMUNICATION LOSS ON ALL INSTALLED RECEIVERS SIMULTANEOUSLY WHICH LASTS ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT EVEN AFTER COMING BACK FROM REPAIR THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING ISSUES WITH INTERMITTENT COMMUNICATION LOSS ON ALL INSTALLED RECEIVERS SIMULTANEOUSLY WHICH LASTS ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT EVEN AFTER COMING BACK FROM REPAIR THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING ISSUES WITH INTERMITTENT COMMUNICATION LOSS ON ALL INSTALLED RECEIVERS SIMULTANEOUSLY WHICH LASTS ANYWHERE FROM 30 SECONDS TO 3 MINUTES. 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. CENTRAL NURSE'S STATION MODEL: PU-681RA SN: NI TELEMETRY TRANSMITTER(S) MODEL: ZM-531PA SN: NI TELEMETRY TRANSMITTER(S) MODEL: ZM-541PA SN: NI