SUPPORT ARM 177
Received Apr 21, 2023 · Event occurred Mar 27, 2023
Report 8010042-2023-00768 · MDR key 16782864
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 177Catalog 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
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT CIRCUIT BROKE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SUPPORT ARM BRACKET BROKE. OUR FIELD SERVICE ENGINEER INVESTIGATED THE VENTILATOR ON SITE AND SOLVED THE ISSUE BY REPLACING THE SUPPORT ARM BRACKET. REGULAR FUNCTIONAL TESTS WERE CARRIED OUT AND THE FAILURE DID NOT CAUSE ANY INJURIES TO PATIENTS OR OPERATORS OR DELAYS IN PROCEDURES. A BROKEN SUPPORT ARM MAY LEAD TO TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THE ROOT CAUSE AS TO WHY THE SUPPORT ARM BRACKET BROKE CANNOT BE ESTABLISHED BY THIS INVESTIGATION.
Description of Event or Problem
MANUFACTURERS REF: #(B)(4).