MalfunctionDRG

ORG-9110A

Received Dec 22, 2021 · Event occurred Nov 26, 2021

Report 2080783-2021-02224 · MDR key 13066885

Device

Generic name

Multiple Patient Receiver

Manufacturer

Nihon Kohden Corporation

Model number

ORG-9110A

Catalog number

ORG-9110A

Lot number

Product problems

Communication or Transmission Problem
Communication or Transmission Problem

Patient

Unknown

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

Narrative

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WENT INTO COMMUNICATION LOSS WITH CONNECTED DEVICES AND WHEN THEY CHECKED OUT THE ORG, THEY SAW THAT IT HAS AN ERROR LIGHT LIT ON IT. NO PATIENT HARM WAS REPORTED. THEY WILL BE SENDING THIS ORG IN FOR AN EXCHANGE.