SUPPORT ARM 177
Received May 9, 2023 · Event occurred May 2, 2023
Report 8010042-2023-00892 · MDR key 16894703
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
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM 177 WAS BROKEN. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION, SERVICE REPORT, COMMUNICATION WITH FIELD SERVICE ENGINEER (FSE) AND PROVIDED PICTURE. BASED ON TECHNICIAN STATEMENT IT WAS CONCLUDED THAT THE SUPPORT ARM WAS BROKEN AT THE JOINT NEAREST THE BRACKET. THE SUPPORT ARM HAS BEEN REPLACED TO RESOLVE THE ISSUE. THE ISSUE WAS DECIDED TO BE REPORTED AS THE BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATING) OR INJURY. THERE WAS NO PATIENT HARM. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. THE CORRECTION OF FIELD G4 DATE RECEIVED BY MANUFACTURER WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS DATE RECEIVED BY MANUFACTURER: 05/02/2023. CORRECTED DATE RECEIVED BY MANUFACTURER: 04/26/2023.
Description of Event or Problem
MANUFACTURER'S REF. #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM 177 WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).