inforMED
MalfunctionDRG

CENTRAL MONITORING SYSTEM

Received Jan 7, 2022 · Event occurred Dec 7, 2021

Report 2032233-2022-02329 · MDR key 13198586

Device

Generic name

Central Monitoring Station

Manufacturer

Nkus Lab

Model number

EDNS-9001

Catalog number

EDNS-9001

Lot number

NA

Product problems

  • Application Program Problem
  • Unintended Application Program Shut Down
  • Application Program Problem
  • Unintended Application Program Shut Down

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PREFENSE SYSTEM WAS SHUTTING DOWN. THEY WERE ABLE TO GET THE DEVICE BACK ON LAST NIGHT, BUT THEY HAVE NOTICED THAT THE POWER LIGHT IS FLASHING, AND THE UNIT IS NOT DISPLAYING CONTENT. TECH SUPPORT (TS) INFORMED THEM THAT THIS WAS AN END OF LIFE DEVICE. THE CUSTOMER LATER TOLD TECH SUPPORT STATED THAT THEY WILL BE REPLACING THE MOTHERBOARD ON THIS DEVICE. THIS WAS NOT IN PATIENT USE. 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.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PREFENSE SYSTEM WAS SHUTTING DOWN. THEY WERE ABLE TO GET THE DEVICE BACK ON LAST NIGHT, BUT THEY HAVE NOTICED THAT THE POWER LIGHT IS FLASHING, AND THE UNIT IS NOT DISPLAYING CONTENT. TECH SUPPORT (TS) INFORMED THEM THAT THIS WAS AN END OF LIFE DEVICE. THE CUSTOMER LATER TOLD TECH SUPPORT STATED THAT THEY WILL BE REPLACING THE MOTHERBOARD ON THIS DEVICE. THIS WAS NOT IN PATIENT USE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PREFENSE SYSTEM WAS SHUTTING DOWN ON ITS OWN. THEY WERE ABLE TO GET THE DEVICE BACK UP AND RUNNING, BUT NOTICED THAT THE POWER LIGHT WAS FLASHING, AND THE UNIT WAS NOT DISPLAYING CONTENT. TECH SUPPORT (TS) INFORMED THEM THAT THIS WAS AN END OF LIFE DEVICE. THIS WAS NOT IN PATIENT USE.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PREFENSE SYSTEM WAS SHUTTING DOWN ON ITS OWN. THEY WERE ABLE TO GET THE DEVICE BACK UP AND RUNNING, BUT NOTICED THAT THE POWER LIGHT WAS FLASHING, AND THE UNIT WAS NOT DISPLAYING CONTENT. TECH SUPPORT (TS) INFORMED THEM THAT THIS WAS AN END-OF-LIFE DEVICE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: TS INFORMED THE CUSTOMER THAT THE DEVICE WAS NO LONGER SUPPORTED AS IT IS IN END OF LIFE AND COULD NO LONGER BE SENT IN FOR REPAIR. THE DEVICE HAD BEEN IN SERVICE SINCE (B)(6) 2012. A REVIEW OF THE HISTORY OF THE SERIAL NUMBER IDENTIFIED NO SIMILAR EVENTS. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. SINCE THE DEVICE WAS ALREADY IN END OF LIFE/SERVICE, IT IS POSSIBLE THAT THE INTERNAL HARDWARE (I.E. POWER SUPPLY, HDD) OF THE DEVICE MAY HAVE FAILED DUE TO WEAR AND TEAR AND HAD CAUSED THE ISSUE. THE ISSUE IS REGARDING A PRODUCT THAT IS ALREADY IN END OF LIFE/SERVICE. 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 H10 ADDITIONAL MANUFACTURER NARRATIVE.