SUPPORT ARM 176
Received Mar 8, 2021 · Event occurred Feb 9, 2021
Report 8010042-2021-00507 · MDR key 11432861
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE.
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR¿S SUPPORT ARM HOLDING THE PATIENT TUBES BROKE. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).