inforMED
OtherILK

LEVANT BASIC

Received Aug 8, 2012 · Event occurred Aug 1, 2011

Report 3006395295-2012-00003 · MDR key 2696491

Device

Generic name

Powered Patient Transport 890.5150

Model number

LEVANT

Lot number

NA

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Fall

Narrative

Description of Event or Problem

THE USER OF A POWERED PATIENT TRANSPORT FELL FROM THE CHAIR AND REQUIRED 20-25 STITCHES TO HIS FACE. THIS EVENT WAS NOT REPORTED AT THE TIME IT HAPPENED EVEN THOUGH THE DEALER WAS CALLED IN TO DO A SERVICE VISIT. THIS EVENT WAS REPORTED IN CONJUNCTION WITH A SECOND EVENT INVOLVING THE SAME UNIT (SEE MFR # 3006395295-2012-00004). BOTH EVENTS OCCURRED IN (B)(6). AFTER RECEIVING THE SECOND REPORT AND DOING AN INVESTIGATION, THE MANUFACTURER HAS DECIDED TO INITIATE A PRODUCT FIELD UPDATE.

Remedial action

  • Repair