NI
Received Nov 19, 2021 · Event occurred Oct 20, 2021
Report 2080783-2021-02088 · MDR key 12849555
Device
Generic name
Multiple Patient Receiver
Manufacturer
Nihon Kohden CorporationModel number
NICatalog number
NI
Lot number
NA
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 REPORTED THAT THEY ARE REPLACING THE MULTIPLE PATIENT RECEIVER (ORG) WITH A SPARE UNIT, BUT WHEN THEY ATTEMPT TO CONNECT IT TO THE HOSPITAL NETWORK, THE TELEMETRY TRANSMITTER UNITS ASSOCIATED WITH THE ORG FAILS TO SHOW UP ON THE CENTRAL NURSE'S STATION (CNS). THIS WAS NOT IN PATIENT USE WHEN THIS HAPPENED. HOWEVER, THE DESCRIPTION OF FAILURE IS UNKNOWN FOR THE INITIAL ORG THAT WAS BEING TAKEN OUT OF COMMISSION. IT IS UNKNOWN WHETHER IT WAS IN PATIENT USE WHEN IT FAILED, OR WHAT THE MODEL AND SERIAL NUMBER OF THE DEVICE IS. THE CUSTOMER HAS BEEN UNRESPONSIVE TO INQUIRIES. IF THE UNIT FAILED WHILE IN PATIENT USE, THIS WOULD MOST LIKELY BE A REPORTABLE ISSUE. THEREFORE, TO ERR ON THE SIDE OF CAUTION; THIS IS BEING REPORTED. NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
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