inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Nov 23, 2020 · Event occurred Oct 12, 2020

Report 8010042-2020-01045 · MDR key 10883598

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 177

Catalog number

6481720

Product problems

  • Break
  • Break

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND REPLACED THE BROKEN SUPPORT ARM AND THE VENTILATOR RETURNED TO CLINICAL USE. ACCORDING TO THE RECEIVED PICTURE FROM THE FSE, 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM OF THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF.#: (B)(4).