inforMED
MalfunctionKQS

HUT EXT DR FINAL ASSY-REVERSE

Received Feb 28, 2012 · Event occurred Feb 16, 2012

Report 1518293-2012-00041 · MDR key 2480328

Device

Model number

HUT EXT DR

Catalog number

404007

Lot number

NA

Product problems

  • Device Inoperable

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

(B)(6): CUSTOMER REPORTS WHEN STAFF ATTEMPTED TO START THE UROLOGY SYSTEM FOR DAYS PROCEDURES, THE MONITORS FAILED TO WORK. PATIENT PROCEDURES WERE CANCELED. CUSTOMER DOES NOT HAVE A BACK UP ROOM. NO REPORTED INJURIES. CUSTOMER REPORTS ALL PROCEDURES HAVE BEEN DELAYED PENDING ROOM REPAIR.

Additional Manufacturer Narrative

FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE NO FLUORO IMAGE PROBLEM AND FOUND BOTH MONITORS ON TOWER WORKED IN LAST IMAGE HOLD (LIH) CHANNEL 11. FSE THEN SWAPPED VIDEO INPUT AT THE MONITORS AND IMAGE SWAPPED, THEN FSE WENT TO BNC ON PLATINUM ONE COMPUTER AND FLEXED IT AND THE MONITOR CAME UP IN CHANNEL 10. FSE DETERMINED FROM THIS THAT THE UNIT NEEDS A BNC CABLE PH 704051 OR VIDEO PCB PN 710293. THE UNIT IS CURRENTLY WORKING. WHEN FSE ASKED FOR APPROVAL FROM CUSTOMER FOR PARTS REPLACEMENT, CUSTOMER WANTED TO OPEN ANOTHER SERVICE REQUEST WITH DIFFERENT PO# TO COVER VIDEO PCB 710293, AND BNC CABLE 704051 AND LABOR AT A LATER DATE. FSE COMPLETED HYDRAVISION SERVICE CHECKLIST WITH REFERENCE SERVICE MANUAL, AND FOUND ALL READINGS WITHIN TOLERANCE. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.