inforMED
MalfunctionDRG

ORG-9110A

Received Dec 3, 2021 · Event occurred Nov 5, 2021

Report 2080783-2021-02056 · MDR key 12925479

Device

Generic name

Multiple Patient Receiver

Model number

ORG-9110A

Catalog number

ORG-9110A

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 CUSTOMER REPORTED THAT THE ORG SHOWED 4 TRANSMITTERS IN SIGNAL LOSS. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THEY ALL WENT INTO SIGNAL LOSS AT THE SAME TIME. WHEN THEY INVESTIGATED, THEY COULDN'T FIND ANY ISSUE AND THE ISSUE ITSELF NEVER CAME UP AGAIN. THERE WAS NO PATIENT INJURY REPORTED. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG: ZM TRANSMITTERS: MODEL #: 521, SERIAL #S: (B)(4), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI.