ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SWITCHING BETWEEN DUPLICATE CHANNELS, WITH NO SIGNAL OR READINGS ON THREE TRANSMITTERS. WHEN THE UNIT WAS READING, THE HR WAS CORRECT, BUT THE RESPIRATION RATE WAS WAY OFF AND SHOWING SPIKES. THE BME DUPLICATED THE ISSUE USING DIFFERENT TRANSMITTERS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SWITCHING BETWEEN DUPLICATE CHANNELS, WITH NO SIGNAL OR READINGS ON THREE TRANSMITTERS (SN: (B)(6)). WHEN THE UNIT WAS READING, THE HR WAS CORRECT, BUT THE RESPIRATION RATE WAS WAY OFF AND SHOWING SPIKES. THE BME DUPLICATED THE ISSUE USING DIFFERENT TRANSMITTERS. THE BME EMAILED THAT THEY HAD PLACED EACH TRANSMITTER ON A SIMULATOR, AND THE RESPIRATIONS ON E CHANNELS FOR THESE THREE TRANSMITTERS WERE SHOWING SIGNIFICANTLY OVER 100, WITH THE GRAPH DISPLAYING SPIKES AND ERRATIC JUMPS. THE BME WAS SENDING IT 20 ACROSS THEIR SIMULATOR. THOSE SAME E CHANNELS WERE ALSO BOUNCING BETWEEN SIGNAL LOSS, DUPLICATE CHANNEL, AND SHOWING VITALS, BUT WITH THE WRONG RESPIRATIONS. WHEN TESTING THE TRANSMITTERS WITH A SIMULATOR, THEY USED A CNS (PU-6801, SN: (B)(6)) AND THIS ORG (SN: (B)(6)). THE BME USED A KNOWN WORKING ORG IN THE SAME LOCATION AS THE ONE WITH ISSUES, AND EVERYTHING WORKED WITHOUT ANY ISSUES. NO PATIENT HARM WAS REPORTED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NOV. 10, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: SEPT. 10, 2020. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: OCT. 19, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NOV. 11, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: MARCH 11, 2019. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: APRIL 24, 2019. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SWITCHING BETWEEN DUPLICATE CHANNELS, WITH NO SIGNAL OR READINGS ON THREE TRANSMITTERS SN: (B)(6), (B)(6), (B)(6). WHEN THE UNIT WAS READING, THE HR WAS CORRECT, BUT THE RESPIRATION RATE WAS WAY OFF AND SHOWING SPIKES. THE BME DUPLICATED THE ISSUE USING DIFFERENT TRANSMITTERS. THE BME EMAILED THAT THEY HAD PLACED EACH TRANSMITTER ON A SIMULATOR, AND THE RESPIRATIONS ON E CHANNELS FOR THESE THREE TRANSMITTERS WERE SHOWING SIGNIFICANTLY OVER 100, WITH THE GRAPH DISPLAYING SPIKES AND ERRATIC JUMPS. THE BME WAS SENDING IT 20 ACROSS THEIR SIMULATOR. THOSE SAME E CHANNELS WERE ALSO BOUNCING BETWEEN SIGNAL LOSS, DUPLICATE CHANNEL, AND SHOWING VITALS, BUT WITH THE WRONG RESPIRATIONS. WHEN TESTING THE TRANSMITTERS WITH A SIMULATOR, THEY USED A CNS PU-6801, SN: (B)(6) AND THIS ORG SN: (B)(6). THE BME USED A KNOWN WORKING ORG IN THE SAME LOCATION AS THE ONE WITH ISSUES, AND EVERYTHING WORKED WITHOUT ANY ISSUES. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE ROOT CAUSE IS DETERMINED TO BE FAILED RECEIVER CARDS IN THE ORG, WHICH LED TO SIGNAL LOSS AND INCORRECT RESPIRATION READINGS. NK WILL TREND AND MONITOR. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG. CNS. MODEL #: PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NOV. 10, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: SEPT. 10, 2020. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: OCT. 19, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NOV. 11, 2021. UNIQUE IDENTIFIER (UDI) #: (B)(6). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: MARCH 11, 2019. UNIQUE IDENTIFIER (UDI) #: (B)(6). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: APRIL 24, 2019. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS. MODEL #: ZM-531PA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NI. 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 MULTIPLE PATIENT RECEIVER (ORG) WAS SWITCHING BETWEEN DUPLICATE CHANNELS, WITH NO SIGNAL OR READINGS ON THREE TRANSMITTERS. WHEN THE UNIT WAS READING, THE HR WAS CORRECT, BUT THE RESPIRATION RATE WAS WAY OFF AND SHOWING SPIKES. THE BME DUPLICATED THE ISSUE USING DIFFERENT TRANSMITTERS. NO PATIENT HARM WAS REPORTED.