MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES ZIPPIE VOYAGE; STROLLER (CHAIR WITH CASTERS)

Model Number EIZ14

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Swelling (2091); Tooth Fracture (2428)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Sunrise medical has requested with the dealer that the stroller be returned for a full evaluation.The stroller has the slide-n-lock base in which the seating system will slide onto the base and lock into place.The seating system is successfully locked in place when an audible click is heard.Past evaluations have found that if there is an obstruction, the slide-n-lock base and the seating system will not lock and the locking click will not be heard.A replacement stroller was shipped to the dealer on (b)(6) 2017.If there are any relevant findings from the evaluation, a supplemental report will be filed.

Event Description

Per jp, the dealer, on (b)(6) 2017 while the child was at school the teacher was pushing the child around the corner and the seat slid off from the base with the child, hitting the ground.The child was taken to the hospital.The child allegedly has a chipped tooth and a "goose egg" (bump) on her forehead.

Manufacturer Narrative

The stroller in question was received and an evaluation was performed by a sunrise medical quality engineer on 02/20/2018.The following findings were reported from the evaluation: the stroller is a voyage vip model with a serial no.(b)(4) when unpacking the chair was observed that the support of the seating system was loose and also the screws of the base were loose.It was also noted that the harness straps are very long.For purposes of the test, the hitch movement was made in a similar way to how the user would mount the seating system and the straps were not caught.A test of the seating system was made attaching it to the base and adding 40 pounds of weight to simulate the weight of the user.Then a push test was done with the stroller on flat terrain as well as on a dirt road and confirmed that the seating system does not disengage from the base.The seating system did not detach from the base while testing on flat terrain as well on a dirt road.The alleged failure was unable to be duplicated.

Event Description

Please see initial mdr 9616084-2018-00001.

• Brand Name: ZIPPIE VOYAGE
• Type of Device: STROLLER (CHAIR WITH CASTERS)
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 7197758
• MDR Text Key: 97474596
• Report Number: 9616084-2018-00001
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIZ14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 14