inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Jul 20, 2021 · Event occurred Jul 5, 2021

Report 8010042-2021-01783 · MDR key 12195288

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 177

Catalog number

6481720

Product problems

  • Fracture
  • Fracture

Patient

Unknown

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

Narrative

Description of Event or Problem

MANUFACTURER'S REF#: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SUPPORT ARM 177 MOUNTED ON VENTILATOR - SERVO-I WAS BROKEN. THE REPORTED ISSUE HAS BEEN CONFIRMED DURING EVALUATION OF THE PROVIDED PROBLEM DESCRIPTION AND SERVICE REPORT. BASED ON INFORMATION PROVIDED, THE ISSUE WAS RESOLVED BY REPLACING SUPPORT ARM 177. THE PHOTO OF THE BROKEN PART WAS NOT AVAILABLE FOR FURTHER EVALUATION. THE MAIN FUNCTION OF SUPPORT ARM IS CARRYING THE PATIENT TUBES, WHICH CONNECTS THE VENTILATOR TO THE PATIENT. IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, THE FAULTY PART HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS AS IT WAS DISCARDED. THEREFORE, THE ROOT CAUSE OF THE FAILURE CANNOT BE ESTABLISHED.

Description of Event or Problem

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