inforMED
MalfunctionLBE

ZIPPIE VOYAGE

Received Aug 15, 2017 · Event occurred Jul 18, 2017

Report 9616084-2017-00004 · MDR key 6796140

Device

Generic name

Stroller (chair With Casters)

Model number

EIZ4

Product problems

  • Detachment Of Device Component
  • Component Falling

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

AN EVALUATION WAS PERFORMED BY SUNRISE MEDICAL'S QUALITY INSPECTOR, WHO CONFIRMED THAT THE LATCHES ON THE SEATING SYSTEM WERE NOT WORKING PROPERLY AND NOT LOCKING INTO PLACE. THIS OCCURS OVER TIME AS THE LATCHES WEAR FROM CONSTANT USE. THE ZIPPIE VOYAGE OWNER'S MANUAL STATES ON PAGE 6, SECTION D. SAFETY CHECKLIST, TO INSPECT THE CHAIR PRIOR TO EACH USE. POINT 5 IN SECTION STATES, NEVER SEAT YOUR CHILD IN THE MOBILITY DEVICE UNTIL IT IS FULLY UNFOLDED AND LOCKED. POINT 3 STATES, REPAIR ANY PROBLEMS THAT ARE ENCOUNTERED. IT WAS DECIDED TO NOT REPLACE THE LATCHES ON THE ORIGINAL STROLLER, BUT TO UPGRADE TO THE NEWER MODEL STROLLER THAT COMES EQUIPPED WITH THE NEW SLIDE-N-LOCK SEATING SYSTEM. THIS ALLOWS THE SEAT TO LOCK AT THE BASE AND NOT ON THE SIDES AS THE LATCH SYSTEM DID ON THE OLDER MODEL. THE NEW CHAIR WAS DELIVERED TO THE DEALER ON (B)(6) 2017. THERE HAVE BEEN NO OTHER INCIDENTS REPORTED SINCE.

Description of Event or Problem

PLEASE SEE INITIAL MDR 9616084-2017-00004.

Additional Manufacturer Narrative

SUNRISE MEDICAL HAS REQUESTED FROM THE DEALER THE RETURN OF THE STROLLER FOR A FULL EVALUATION. UNABLE TO DETERMINE AT THIS TIME IF A MALFUNCTION OCCURRED OR IF THE PRODUCT IS DEFECTIVE. A NEW REPLACEMENT STROLLER WAS PROVIDED AND DELIVERED TO THE DEALER ON (B)(6) 2017. ONCE THE ORIGINAL STROLLER IS RECEIVED BY SUNRISE MEDICAL, A FULL EVALUATION WILL BE PERFORMED, FOLLOWED BY A SUPPLEMENTAL REPORT WITH ANY RELEVANT FINDINGS.

Description of Event or Problem

PER DEALER, (B)(6) THE SEATING SYSTEM FELL OFF THE BASE TWICE WHILE THE PARENTS WERE WALKING OUTSIDE WITH THE END USER IN THE STROLLER. THE SEAT FELL INTO THE STORAGE BELOW AND DID NOT HIT THE GROUND. THE FAMILY STATES THAT THEY WERE UNSURE IF IT WAS THE LATCHES THE FIRST TIME BUT MADE SURE IT WAS PRIOR TO THE SECOND. DEALER STATES THAT THERE IS NO VISIBLE DAMAGE. THE FAMILY ALSO STATED THAT IT ONLY OCCURRED WHILE THE SEAT WAS IN THE REVERSE POSITION. THERE WERE NO INJURIES.

Remedial action

  • Replace