Model Number SUPPORT ARM 177 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
No repair was requested and no parts were returned.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.Previous investigations of similar faults led to a redesign and change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.The support arm associated with this complaint had been manufactured before this change was implemented in production.
|
|
Event Description
|
It was reported that the support arm for patient tubes broke.There was no patient harm.Manufacturer's ref #: (b)(4).
|
|
Search Alerts/Recalls
|