inforMED — FDA medical device performance lookup

Device

Generic name

Receiver Unit

Manufacturer

Nihon Kohden Corporation

Model number

ORG-9700A

Catalog number

MU-970RA

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

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE ORG SHOWED 9 TELES IN SIGNAL LOSS. TECHNICAL SUPPORT (TS) ASKED THE CUSTOMER TO POWER CYCLE THE ORG AND AFTER DOING THAT ONLY 6 OF THE UNITS STILL SHOWED SIGNAL LOSS. THE CUSTOMER FOUND OUT THAT THOSE 6 UNITS HAD NO PATIENTS ON. THE CUSTOMER LATER REPORTED THAT INTERMITTENT SIGNAL LOSS IS STILL HAPPENING. THE CUSTOMER REQUESTED ONSITE SUPPORT. TS IS WORKING WITH THE CUSTOMER TO RESOLVE THE PROBLEM. THERE WAS NO PATIENT INJURY REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ORG SHOWED 9 TELES IN SIGNAL LOSS. TECHNICAL SUPPORT (TS) ASKED THE CUSTOMER TO POWER CYCLE THE ORG AND AFTER DOING THAT ONLY 6 OF THE UNITS STILL SHOWED SIGNAL LOSS. THERE WAS NO PATIENT INJURY REPORTED.