MalfunctionLBE
ZIPPIE VOYAGE
Received Oct 19, 2017 · Event occurred Sep 25, 2017
Report 9616084-2017-00011 · MDR key 6963645
Device
Generic name
Stroller (chair With Casters)
Manufacturer
Sunrise Medical Privada MisionesModel number
EIZ14Product problems
- Component Falling
- Device Operates Differently Than Expected
Patient
2 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A REPLACEMENT STROLLER HAS BEEN SHIPPED TO THE DEALER ON 10/3/2017. SUNRISE MEDICAL HAS REQUESTED WITH THE DEALER TO SHIP THE STROLLER BACK FOR AN EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED WITH ANY RELEVANT FINDINGS FROM THE EVALUATION.
Description of Event or Problem
PER DEALER (B)(6) THE SEAT IS NOT LOCKING INTO PLACE. HE STATES THAT THE SEAT FELL OFF. NO INJURY OCCURRED BECAUSE THE CHILD WAS REAR FACING.
Remedial action
- Replace