inforMED
MalfunctionIOY

SUPPORT ARM 179

Received Aug 10, 2023 · Event occurred Jul 27, 2023

Report 8010042-2023-01539 · MDR key 17497237

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 179

Catalog number

6882001

Product problems

  • Fracture
  • Fracture

Patient

Unknown

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

Narrative

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 THE INFORMATION COLLECTED TO DATE, THE PROVIDED PROBLEM DESCRIPTION AND THE INFORMATION FROM THE CUSTOMER, IT HAS BEEN CLARIFIED THAT SUPPORT ARM 179 HAS BEEN BROKEN. THE USER REPLACED DEFECTIVE PART AND PUT BACK THE UNIT FOR USAGE. THE CUSTOMER CANCELLED SERVICE CALL, THEREFORE OUR TECHNICIAN HAS NOT ATTEMPT ANY ON-SITE INVESTIGATION. NO DETAILS NOR PHOTOS HAVE BEEN PROVIDED REGARDING TO WHICH PART OF SUPPORT ARM BROKE. THE ISSUE WAS DECIDED TO BE REPORTED BROKEN SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. H3 OTHER TEXT : 4117.

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).