inforMED
MalfunctionDRG

ORG-9110A

Received Apr 27, 2026 · Event occurred Apr 2, 2026

Report 8030229-2026-06535 · MDR key 24998418

Device

Generic name

Multiple Patient Receiver

Model number

ORG-9110A

Catalog number

ORG-9110A

Lot number

NA

Product problems

  • Unable to Obtain Readings
  • Communication or Transmission Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REQUESTED NK ONSITE SUPPORT SERVICES FOR INTERMITTENT COMMUNICATION LOSS FOR SEVERAL TELEMETRY DEVICES. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REQUESTED NK ONSITE SUPPORT SERVICES FOR INTERMITTENT COMMUNICATION LOSS FOR SEVERAL TELEMETRY DEVICES. THE BME EMAILED THE RESULTS OF THE REPORT, WHICH DOCUMENTED THAT THIS MULTIPLE PATIENT RECEIVER (ORG) HAD A CRC ERROR MESSAGE. NK SUPPORT ATTEMPTED TO USE THE RESTORE CARD, BUT THE ISSUE PERSISTED. THE ORG WAS CONNECTED TO AN UNINTERRUPTIBLE POWER SUPPLY (UPS) THAT WAS FAULTY. THE SETTINGS FROM THE DEFECTIVE ORG WERE COPIED TO A SPARE UNIT ON SITE, THE UPS WAS REPLACED AND THE ORG WAS RETURNED FOR REPAIR. NO PATIENT HARM WAS REPORTED. 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.