ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ON THE 5TH FLOOR HAS BEEN EXPERIENCING AN ONGOING SIGNAL LOSS TO THE TRANSMITTERS IN SEVERAL ROOMS AND DEPARTMENTS IN THEIR HOSPITAL. NO PATIENT HARM OR MISSED PATIENT EVENTS REPORTED. NIHON KOHDEN TECHNICIAN WENT ON-SITE AND FOUND THAT THE ATTENUATORS' (AAC) WERE DEFECTIVE WHICH THE NK TECHNICIAN REPLACED AND ISSUE IS RESOLVED. ATTENUATORS ARE NOT CONSIDERED TO BE MEDICAL DEVICES.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ON THE 5TH FLOOR HAS BEEN EXPERIENCING AN ONGOING SIGNAL LOSS TO THE TRANSMITTERS IN DIFFERENT ROOMS AND DEPARTMENTS IN THEIR HOSPITAL. NO PATIENT HARM OR MISSED PATIENT EVENTS REPORTED. NIHON KOHDEN TECHNICIAN WENT ON-SITE AND FOUND THAT THE ATTENUATORS' (AAC) WERE DEFECTIVE WHICH THE NK TECHNICIAN REPLACED AND ISSUE IS RESOLVED. ATTENUATORS ARE NOT CONSIDERED TO BE MEDICAL DEVICES. CENTRAL NURSE STATIONS: MODEL #: NI. SERIAL #: NI. ZM TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ON THE 5TH FLOOR HAS BEEN EXPERIENCING AN ONGOING SIGNAL LOSS TO THE TRANSMITTERS IN DIFFERENT ROOMS AND DEPARTMENTS IN THEIR HOSPITAL. NO PATIENT HARM OR MISSED PATIENT EVENTS REPORTED. NIHON KOHDEN TECHNICIAN WENT ON-SITE AND FOUND THAT THE ATTENUATORS' (AAC) WERE DEFECTIVE WHICH THE NK TECHNICIAN REPLACED AND ISSUE IS RESOLVED. ATTENUATORS ARE NOT CONSIDERED TO BE MEDICAL DEVICES. INVESTIGATION SUMMARY: ON-SITE SUPPORT IDENTIFIED THAT THE CAUSE OF THE INTERMITTENT SIGNAL LOSS WAS DUE TO A DEFECTIVE AMPLIFIER COMBINERS OR AAC. AAC'S ARE USED TO ADJUST THE GAINS ON SIGNALS AND CONNECT BETWEEN THE ORG AND ITS' ANTENNAS. DEFECTIVE AAC'S MAY PREVENT PROPER SIGNAL STRENGTH FROM BEING OUTPUTTED OR STOP SIGNALS COMPLETELY. BASED ON THE SALES DATA OF THIS CUSTOMER, THESE AAC'S WERE MOST LIKELY INSTALLED IN 1/2018 WHEN THE ORG WAS FIRST USED IN THEIR FACILITY. THE ROOT CAUSE IS MOST LIKELY RELATED TO WEAR AND TEAR A COMPLAINT HISTORY REVIEW REVEALS THERE IS NO HISTORY FOR THE AAC FAILURE, THEREFORE A CORRECTIVE ACTION OR PREVENTATIVE ACTION (CAPA) IS NOT WARRANTED. ADDITIONAL MANUFACTURER NARRATIVE B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE H6 TYPE OF INVESTIGATION CODE H10 ADDITIONAL NARRATIVE/DATA

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ON THE 5TH FLOOR HAS BEEN EXPERIENCING AN ONGOING SIGNAL LOSS TO THE TRANSMITTERS IN SEVERAL ROOMS AND DEPARTMENTS IN THEIR HOSPITAL. NO PATIENT HARM OR MISSED PATIENT EVENTS REPORTED. NIHON KOHDEN TECHNICIAN WENT ON-SITE AND FOUND THAT THE ATTENUATORS' (AAC) WERE DEFECTIVE WHICH THE NK TECHNICIAN REPLACED AND ISSUE IS RESOLVED. ATTENUATORS ARE NOT CONSIDERED TO BE MEDICAL DEVICES.