inforMED
MalfunctionIOY

SUPPORT ARM 176

Received Aug 4, 2023 · Event occurred Jul 12, 2023

Report 8010042-2023-01499 · MDR key 17457710

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 176

Catalog number

6405976

Product problems

  • Fracture
  • Fracture

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND SERVICE REPORT. BASED ON TECHNICIAN STATEMENT, THE CLAMP MOUNT WAS IDENTIFIED AS FAULTY AND REPLACED. THE CLAMP MOUNT IS A PART OF SUPPORT ARM AND IS MOUNTED DIRECTLY TO THE SERVO DEVICE. THE SUPPORT ARM SERVES TO RELIEVE THE PATIENT FROM THE WEIGHT OF THE TUBING SYSTEM. WHEN MOVING THE SUPPORT ARM OR CHANGING POSITION, THE PATIENT CONNECTION SHOULD BE OBSERVED TO SEE THAT NO PULLING OR OTHER MOVEMENT OCCURS. THE ISSUE WAS DECIDED TO BE REPORTED AS BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THERE WAS NO PATIENT HARM. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.