SUPPORT ARM 177
Received Aug 13, 2015
Report 8010042-2015-00356 · MDR key 5015125
Device
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
FURTHER INFO REGARDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Additional Manufacturer Narrative
(B)(4). ACCORDING TO INFORMATION RECEIVED, THE SUPPORT ARM BROKE AT THE JOINT ABOVE THE FIRST BEND. THE SUPPORT ARM IS BY DESIGN A CASTING PRODUCT. NO PARTS OR PICTURES WERE RECEIVED BACK FOR INVESTIGATION. NEITHER WAS INFORMATION OF HOW OR UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE RECEIVED. PREVIOUS INVESTIGATIONS OF THE SUPPORT ARM LED TO A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. IT IS UNKNOWN IF THE REPORTED SUPPORT ARM WAS MANUFACTURED BEFORE, OR AFTER, THE IMPLEMENTATION OF THIS CHANGE. THEREFORE, THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED.
Description of Event or Problem
(B)(4). THIS FOLLOW-UP MEDWATCH WAS CREATED FROM A PREVIOUSLY RECEIVED INITIAL MEDWATCH WITH MANUFACTURER REPORT # : 8010042-2015-00356. THE ORIGINAL DATE OF THE INITIAL MEDWATCH REPORT WAS 07/24/2015. (B)(4).