SUPPORT ARM 176
Received Jul 31, 2023 · Event occurred Jul 17, 2023
Report 8010042-2023-01460 · MDR key 17423609
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM USED FOR HOLDING THE PATIENT CIRCUIT BROKE. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER AND ISSUE WAS RESOLVED BY REPLACING THE SUPPORT ARM CLAMP. NO PATIENT HARMED. HOWEVER, NO PART RETURNED FOR INVESTIGATION. THEREFORE, NO ROOT CAUSE CAN BE ESTABLISHED. THERE WAS NO PATIENT HARM. PRE-USE CHECK FAILURE ALSO REPORTED DUE TO LEAK IN THE EXPIRATORY CASSETTE. ISSUE RESOLVED BY CLEANING THE EXPIRATORY CASSETTE MEMBRANE. THE MOST PROBABLE ROOT CAUSE TO THE REPORTED ISSUE WAS THAT THERE WAS DIRT ON THE EXPIRATORY CASSETTE MEMBRANE. IT IS VERY IMPORTANT THAT THE VALVE MEMBRANE AND THE MEMBRANE SEAT IN THE EXPIRATORY CASSETTE ARE CLEAN. IF THERE IS DIRT PARTICLES ON THE VALVE MEMBRANE IT MAY NOT SEAL TO MEMBRANE SEAT CORRECTLY. DIRT PARTICLES CAN CREATE LEAKAGE IN THE EXPIRATORY CASSETTE.
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM USED FOR HOLDING THE PATIENT CIRCUIT BROKE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).