inforMED
MalfunctionILY

VECTRA GENISYS

Received Jul 8, 2011

Report 1022819-2011-00007 · MDR key 2181222

Device

Generic name

Ultrasound 2 Channel

Model number

2761

Catalog number

UNK

Product problems

  • Overheating of Device
  • Device Displays Incorrect Message

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

UNIT WAS REPORTED BY PHYSICIAN AS BEING TOO HOT TO TREAT PTS. THERE WAS NO REPORTED INJURY OR PT INVOLVEMENT. THERE WAS NO MEDICAL INTERVENTION REPORTED FOR THIS EVENT. THE PHYSICIAN RETURNED THE PRODUCT TO THE COMPANY FOR REVIEW AND REPAIR. NO TREATMENT ERRORS WERE FOUND AND A HARDWARE ERROR IS BEING INVESTIGATED.