SUPPORT ARM 177
Received Dec 30, 2022 · Event occurred Dec 6, 2022
Report 8010042-2022-02352 · MDR key 16079353
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 HOLDING THE PATIENT CIRCUIT BROKE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
IT WAS CLAIMED THAT THE SUPPORT ARM HOLDING THE PATIENT CIRCUIT BROKE. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND INFORMATION PROVIDED FROM FIELD SERVICE ENGINEER (FSE). THERE WAS NO PATIENT HARM. BASED ON TECHNICIAN STATEMENT, DURING PREVENTIVE MAINTENANCE VISIT THE SUPPORT ARM WAS NOT BROKEN. THE ACCESSORIES WAS MISSING FROM THE VENTILATOR. THE PART MUST BE PURCHASED TO RESOLVE THE ISSUE. THE COMPLAINT WAS DECIDED TO BE REPORTED BASED ON AVAILABLE INFORMATION (NO INFORMATION ABOUT WHY SUPPORT ARM NEEDS TO BE REPLACED), AS THE INITIAL DESCRIPTION MIGHT HAVE UNDERLYING CAUSES WHICH REPRESENT A REPORTABLE EVENT. IN THE FURTHER PROCESS OF COMPLAINT HANDLING THE ISSUE WAS RELATED TO MISSING SUPPORT ARM. THIS ISSUE WILL NOT AFFECT ONGOING VENTILATION. IT REMAINS UNKNOW WHY THE PART WAS MISSING. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).