ORG-9100A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR TRANSMITTERS (ZM-530PA, SN: 8725) DROPPED OFF THE NETWORK. THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: UNKNOWN) WAS ONLY SHOWING SEVEN OF THE EIGHT RECEIVER CARDS. NOT IN PATIENT USE. TECHNICAL SUPPORT HAD THE BME REBOOT THE ORG, BUT WHEN THAT DID NOT RESOLVE THE ISSUE, THE BME REPLACED THE RECEIVER CARD. WHICH RESOLVED THE ISSUE. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D4 (SERIAL NUMBER). THE UDI # DOES NOT INCLUDE THE SN (PI #), AS ATTEMPTS TO OBTAIN THE SN WERE MADE, BUT NOT PROVIDED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL#: NI, SERIAL#: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI)#: NI, RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER(S): MODEL#: ZM-530PA, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR TRANSMITTERS DROPPED OFF THE NETWORK. THE MULTIPLE PATIENT RECEIVER (ORG) WAS ONLY SHOWING SEVEN OF THE EIGHT RECEIVER CARDS. NOT IN PATIENT USE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR TRANSMITTERS DROPPED OFF THE NETWORK. THE MULTIPLE PATIENT RECEIVER (ORG) WAS ONLY SHOWING SEVEN OF THE EIGHT RECEIVER CARDS. NOT IN PATIENT USE.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR TRANSMITTERS (ZM-530PA, SN: (B)(6) DROPPED OFF THE NETWORK. THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: UNKNOWN) WAS ONLY SHOWING SEVEN OF THE EIGHT RECEIVER CARDS. NOT IN PATIENT USE. TECHNICAL SUPPORT HAD THE BME REBOOT THE ORG, BUT WHEN THAT DID NOT RESOLVE THE ISSUE, THE BME REPLACED THE RECEIVER CARD. WHICH RESOLVED THE ISSUE. INVESTIGATION SUMMARY: THE ROOT CAUSE IS DETERMINED TO BE A FAILED RECEIVER CARD, WHICH CAUSED LOSS OF COMMUNICATION WITH THE AFFECTED TRANSMITTER. NK WILL TREND AND MONITOR. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER(S): MODEL #: ZM-530PA, SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. 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.