SUPPORT ARM 176
Received Dec 11, 2023 · Event occurred Nov 20, 2023
Report 8010042-2023-02417 · MDR key 18300177
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE VENTILATOR'S SUPPORT ARM. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER AND ISSUE RESOLVED BY REPLACING THE BROKEN SUPPORT ARM. HOWEVER, NO PART RETURNED FOR INVESTIGATION. THEREFORE, NO ROOT CAUSE CAN BE ESTABLISHED.
Description of Event or Problem
MANUFACTURER'S REF. #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE VENTILATOR'S SUPPORT ARM. NO MORE INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).