SUPPORT ARM 176
Received Aug 22, 2023 · Event occurred Aug 7, 2023
Report 8010042-2023-01619 · MDR key 17595107
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
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).
Description of Event or Problem
MANUFACTURER'S REF. #: (B)(4).
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION, SERVICE REPORT, COMMUNICATION WITH FIELD SERVICE TECHNICIAN (FSE) AND PROVIDED PICTURE. IT WAS REVEALED THAT CLAMP ATTACHMENT OF SUPPORT ARM WAS DEFECTIVE. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, THE CUSTOMER BOUGHT A NEW SUPPORT ARM TO RESOLVE THE PROBLEM. THE ISSUE WAS DECIDED TO BE REPORTED AS THE BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THERE WAS NO PATIENT HARM. THE MOST LIKELY ROOT CAUSE IS RELATED TO USABILITY AND TO DESIGN LEVEL AT THE SUPPLIER. H3 OTHER TEXT : 4112.