inforMED
MalfunctionGCD

OPERATING TABLE TRUSYSTEM 7000 U

Received May 7, 2021 · Event occurred Apr 8, 2021

Report 3007143268-2021-00007 · MDR key 11789476

Device

Generic name

Table, Operating-room, Electrical

Model number

1604788

Product problems

  • Unintended Movement
  • Unintended Movement

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE INVESTIGATION OF THIS COMPLAINT COULD NOT REVEAL A CLEAR ROOT CAUSE. CONSIDERING ALL FACTS PROVIDED BY THE CUSTOMER AND THE DEVICE EVALUATION BY A FIELD SERVICE TECHNICIAN, THE EVENT IS MOST LIKELY CAUSED BY A COLLISION OF THE TABLETOP WITH THE FLOOR OR FOREIGN EQUIPMENT. NO EVIDENCE OF A DEVICE MALFUNCTION OR FAILURE WAS IDENTIFIED. THE PREVIOUS NOTICED MISSING FOOT LOCK PAD HAD NO IMPACT TO THE ALLEGED TILTING/ LIFTING FROM THE FLOOR OF THE OR-TABLE. BASED ON THIS NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER ALLEGED DURING A CASE THE OR-TABLE WAS MOVED INTO REVERSE TRENDELENBURG AND THE FOOT SIDE OF THE DEVICE BASE CAME OFF THE GROUND. NO INJURY WAS REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

A DEVICE EVALUATION BY A FIELD SERVICE TECHNICIAN IDENTIFIED A MISSING FOOT LOCK PAD WHICH SHOULD NOT BE THE CAUSE FOR THE ALLEGATION. FURTHER INVESTIGATION FOR THE ALLEGATION IS CURRENTLY ONGOING. IF NEW RELEVANT INFORMATION WILL BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE PROVIDED.

Description of Event or Problem

THE CUSTOMER ALLEGED DURING A CASE THE OR-TABLE WAS MOVED INTO REVERSE TRENDELENBURG AND THE FOOT SIDE OF THE DEVICE BASE CAME OFF THE GROUND. NO INJURY WAS REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).