MalfunctionIOY
SUPPORT ARM 179
Received Oct 30, 2020 · Event occurred Sep 11, 2020
Report 8010042-2020-00880 · MDR key 10761769
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 179Catalog number
6882001
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
MANUFACTURER REF#: (B)(4).
Additional Manufacturer Narrative
THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER ON-SITE. THE SUPPORT ARM WAS IDENTIFIED DEFECTIVE. THE PART WAS RETURNED TO MANUFACTURER FOR TECHNICAL INVESTIGATION AND ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED COMPONENT FAILURE HAS NOT BEEN ESTABLISHED IN THIS INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FIXING PLATE GOT DETACHED. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).