MAUDE Adverse Event Report: SUNRISE MEDICAL TECNOLOGIAS S.A. DE CV. ZIPPIE VOYAGE; CHAIR, WITH CASTERS

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  Injury  

Event Description

Could have injured my child; as i'm using the wheelchair stroller i went to pull up one step to come in the house, and the whole seat part tilted back to the ground to the point my daughter could have went back and hit her head.I will upload a pic of the chair so you can see how far it tilts back.Fda safety report id# (b)(4).

• Brand Name: ZIPPIE VOYAGE
• Type of Device: CHAIR, WITH CASTERS
• Manufacturer (Section D): SUNRISE MEDICAL TECNOLOGIAS S.A. DE CV.
• MDR Report Key: 12788342
• MDR Text Key: 280770490
• Report Number: MW5105252
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 25 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American