CENTRAL MONITORING SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT THERE'S NO SOUND COMING OUT OF THIS UNIT. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THERE'S NO SOUND COMING OUT OF THIS UNIT. ACCORDING TO THE CUSTOMER, THERE'S AN AUDIO CABLE THAT WORKS LIKE A KVM AUX REPEATER BOX. THEY USE THIS TO SEND THE SOUND OUT TO THE SCREENS ON THE HALLWAY. WHEN ADJUSTING THE VOLUME SLIDER, THE SOUND IS ONLY HEARD IN THE HALLWAY SCREENS. USUALLY, THE SOUND/ALARM IS HEARD AT BOTH THE HALLWAY AND THE PREFENCE SYSTEM. THE CUSTOMER WILL UPGRADE AS THE PREFENCE IS DISCONTINUED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER WAS INFORMED THAT THE PREFENSE SYSTEM HAS ALREADY BEEN DISCONTINUED. A REVIEW OF THE HISTORY OF THE SERIAL NUMBER IDENTIFIED NO PREVIOUS COMPLAINTS AGAINST THE DEVICE. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. B6 ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. B7 ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. D10 ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. THE FOLLOWING FIELDS ARE NOT AVAILABLE (N/A) TO THIS REPORT: ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? H10 ADDITIONAL MANUFACTURER NARRATIVE. MANUFACTURER REFERENCES # (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THERE'S NO SOUND COMING OUT OF THIS UNIT. ACCORDING TO THE CUSTOMER, THERE'S AN AUDIO CABLE THAT WORKS LIKE A KVM AUX REPEATER BOX. THEY USE THIS TO SEND THE SOUND OUT TO THE SCREENS ON THE HALLWAY. WHEN ADJUSTING THE VOLUME SLIDER, THE SOUND IS ONLY HEARD IN THE HALLWAY SCREENS. USUALLY, THE SOUND/ALARM IS HEARD AT BOTH THE HALLWAY AND THE PREFENCE SYSTEM. THE CUSTOMER WILL UPGRADE AS THE PREFENCE IS DISCONTINUED. 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 INFORMATION WERE MADE, BUT NOT PROVIDED: PATIENT INFORMATION: ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. RELEVANT TESTS AND LABORATORY DATA: ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. OTHER RELEVANT HISTORY: ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. CONCOMITANT MEDICAL PRODUCTS: ATTEMPT # 1: 02/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/28/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 03/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT & DEVICE INFORMATION: NO REPLY WAS RECEIVED. THE FOLLOWING IS NOT AVAILABLE (N/A) TO THIS REPORT: DEVICE MANUFACTURE DATE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THERE'S NO SOUND COMING OUT OF THIS UNIT. THERE WAS NO PATIENT INJURY REPORTED.