SAVARIA
Received May 9, 2017 · Event occurred Feb 7, 2014
Report 3005753836-2016-00003 · MDR key 6554078
Device
Product problems
- Loose or Intermittent Connection
- Mechanical Problem
Patient
12 YR
- Fall
- No Code Available
- Fall
- No Code Available
Narrative
Additional Manufacturer Narrative
TOTAL UNITS EFFECTED IN THE UNITED STATES = (B)(4). AS OF REPORTING APRIL 1 2016 - (B)(4) UNITS REMAIN NOT CORRECTED. THE FOLLOWING DATES ARE CONTACTS WITH DEALERS BY PHONE AND/OR EMAIL TO ENFORCE THE REQUIREMENT TO CORRECT THE WELDED PART. INITIAL PARTS ORDER AND SHIPMENT DATE: 02/18/2014. FOLLOW UP FOR WORK COMPLETION DATE: APRIL 2014, JULY 2014 , DECEMBER 2014, FEBRUARY 2015, APRIL 2015 - DEALERS REQUESTING NEW KITS WERE SENT: AUGUST 2015, DECEMBER 2015, FEBRUARY 2016, MARCH 2016.
Description of Event or Problem
DURING NORMAL OPERATION, THE LIFT WHILE CARRYING A PASSENGER AND WHEELCHAIR IN THE DOWN DIRECTION CAME UNFASTENED FROM THE UPPER LIFTING TROLLEY AND LIFTING CABLE. THE CARRIAGE AND PLATFORM NOW RELEASED FROM THE CABLE SYSTEM SLID DOWN THE LENGTH OF STAIRS BEING GUIDED BY THE LOWER TROLLEY THAT REMAINED CONNECTED. THE PLATFORM HIT THE BOTTOM LANDING CAUSING THE RIDER TO BE THROWN FORWARD HITTING THEIR HEAD AGAINST THE WALL. IT WAS FOUND THAT THE 5 BOLTS THAT WERE HOLDING THE CARRIAGE TO THE UPPER TROLLEY WORKED LOOSE AND EVENTUALLY FAILED RELEASING THE PLATFORM.
Remedial action
- Repair