MalfunctionKIK
MAQUET FEMUR HOOK WITH SUPPORT ARM
Received Feb 19, 2014
Report 8010652-2014-00002 · MDR key 3716277
Device
Generic name
Hook, Bone, Product Code Kik
Manufacturer
Maquet GmbhProduct problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
A MAQUET FIELD SERVICE TECHNICIAN INSPECTED THE ACCESSORY AND FOUND IT HAD BEEN DAMAGED. THE DEVICE WAS REMOVED FROM SERVICE AND A NEW UNIT PROVIDED TO THE CUSTOMER. THE DAMAGE DEVICE IS BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. (B)(4).
Remedial action
- Other