inforMED
MalfunctionIWY

ADAPTER X-RAY 3-JOINT WIDE

Received Apr 4, 2022 · Event occurred Mar 11, 2022

Report 3007143268-2022-00008 · MDR key 13994097

Device

Generic name

Holder, Head, Radiographic

Model number

1430024

Product problems

  • Activation, Positioning or Separation Problem
  • Activation, Positioning or Separation Problem

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THE X-RAY ADAPTER SLIPPED DURING A PROCEDURE AND THE PATIENT'S HEAD MOVED. THE CUSTOMER REPORTED THE ADAPTER WAS MISSING A SCREW BUT DID NOT KNOW IF IT WAS MISSING DURING THE CASE. NO PATIENT INJURY WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

INSPECTION OF THE DEVICE BY A HILLROM TECHNICIAN FOUND NO ISSUE WITH ADAPTER, IT COULD BE FIXED CORRECTLY. THE TECHNICIAN NOTED THAT ONE SCREW (CLAMPING SCREW FOR LONGITUDINAL SHIFT) WAS MISSING WHICH DID NOT CAUSE ANY UNWANTED MOVEMENT. THE HILLROM SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE ANY UNWANTED MOVEMENT. THE FACILITY'S BIOMED ORDERED THE REPLACEMENT SCREW. THE DEVICE IFU STATES "TEST BEFORE EACH USE, CHECK THAT ALL MECHANICAL FUNCTIONS AND PARTS ARE UNDAMAGED AND IN GOOD WORKING ORDER, CHECK IF ALL LOCKING SCREWS¿. THE EVENT WAS TRACED TO AN USE ERROR AND IS REPORTED BASED ON A POTENTIAL SERIOUS INJURY IN CASE OF RECURRENCE. BASED ON THE FINDINGS NO FURTHER ACTIONS ARE REQUIRED.