ORG-9110A

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ERROR LIGHT IS LIT ON THIS MULTIPLE PATIENT RECEIVER (ORG) AND THAT ALL MONITORED TRANSMITTERS ARE SHOWING COMMUNICATION LOSS ON THEIR CENTRAL NURSE'S STATION (CNS). NO HARM OR INJURY OCCURRED.

Additional Manufacturer Narrative

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 Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT AN ERROR LIGHT ON THE MULTIPLE PATIENT RECEIVER (ORG) WAS LIT, AND ALL MONITORED TRANSMITTERS WERE SHOWING COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: AN ERROR MESSAGE WOULD APPEAR TO ALERT CLINICIANS TO THE ISSUE IN WHICH AN ALTERNATE MONITORING METHOD COULD BE PREPARED. THE UNIT'S SOFTWARE WAS REINSTALLED BY NIHON KOHDEN REPAIR CENTER (NK RC) TO RESOLVE THE ISSUE OF ERROR LIGHT AND COMMUNICATION LOSS. AS LOGS WERE NOT RETRIEVED, A ROOT CAUSE CANNOT BE DETERMINED. THE CAUSE OF THE ISSUE LIKELY RELATED TO THE SOFTWARE ON THE ORG. DUE TO THE LOW OCCURRENCE OF THE REPORTED ISSUE, IT IS UNLIKELY THAT THE CAUSE OF THE ISSUE IS RELATED TO THE DESIGN OF THE ORG SOFTWARE. THE SOFTWARE WAS POSSIBLY CORRUPTED DUE TO IMPROPER SHUTDOWNS OR POWER LOSS.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ERROR LIGHT ON THE MULTIPLE PATIENT RECEIVER (ORG) WAS LIT, AND ALL MONITORED TRANSMITTERS WERE SHOWING COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). NO HARM OR INJURY OCCURRED.