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LEVANT BASIC

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

Report 3006395295-2012-00005 · MDR key 2729299

Device

Generic name

Powered Patient Transport 890.5150

Model number

LEVANT

Lot number

NA

Product problems

  • Component Falling

Patient

Not reported

  • Fall
  • Injury

Narrative

Description of Event or Problem

THE SEAT ON A POWERED PT TRANSPORT CAME OFF, CAUSING THE USER TO FALL. THE EVENT OCCURRED WHILE THE USER WAS GETTING ONTO THE LIFT AND BEFORE THE USER WAS ABLE TO SECURE THE SEATBELT. THE FALL CAUSED A SHOULDER INJURY FOR WHICH THE USER LATER WAS TREATED IN THE HOSPITAL. THIS EVENT OCCURRED IN (B)(6). THE CAUSE OF THE EVENT WAS NOT INITIALLY DISCOVERED. AFTER RECEIVING ADDITIONAL INFO AND DOING AN INVESTIGATION, THE MANUFACTURER HAD DECIDED TO INITIATE A PRODUCT FIELD UPDATE.

Additional Manufacturer Narrative

.

Remedial action

  • Repair