inforMED
MalfunctionIOY

SUPPORT ARM 178

Received Apr 5, 2023 · Event occurred Mar 27, 2023

Report 8010042-2023-00695 · MDR key 16681671

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 178

Catalog number

6693715

Product problems

  • Fracture
  • Fracture

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

IT WAS CLAIMED THAT SUPPORT ARM 178 MOUNTED ON SERVO-U VENTILATOR HAS BEEN BROKEN. THERE WAS NO PATIENT HARM. BASED ON TECHNICIAN STATEMENT, THE THERE IS NO INFORMATION HOW BREAKAGE OCCURRED. ACCORDING TO THE PROVIDED PHOTO, SUPPORT ARM BROKE ON THE LOCKING JOINT. WHOLE ARM HAS BEEN REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THE PART HAS BEEN NOT AVAILABLE FOR THE FURTHER ANALYZE OF THE ISSUE. THEREFORE, THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED.

Description of Event or Problem

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