MalfunctionIOY
SUPPORT ARM 179
Received Jun 29, 2021
Report 8010042-2021-01547 · MDR key 12088426
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 179Catalog number
6882001
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE VENTILATOR WAS WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER ON-SITE. THE SUPPORT ARM WAS IDENTIFIED DEFECTIVE. NO PART HAS BEEN RETURNED TO MANUFACTURER FOR TECHNICAL INVESTIGATION. THE CAUSE OF THE REPORTED COMPONENT FAILURE HAS NOT BEEN ESTABLISHED IN THIS INVESTIGATION.
Description of Event or Problem
MANUFACTURER REF#: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE ANGLE ADJUSTMENT HANDLE OF THE SUPPORT ARM COMES OFF. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).