MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC ZIPPIE; EARLY INTERVENTION STROLLER

Model Number	ZIPPIE VOYAGE
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Head Injury (1879)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discussion: a voluntary medwatch report (mw5149183) was submitted detailing an incident involving a zippie voyage wheelchair.In the report, the end user's mother states that she slid the seat onto the stroller base.The mother reports that she checked the seat to confirm it was locked by pushing and pulling the seat as instructed by the original technician.The end user was then strapped into the wheelchair.When walking in the end user's pediatrician's office and going over the doorframe, the seat allegedly "flipped upside down.The most probable root cause could be inadequate attachment of the seat to the stroller base.There was no mention of the safety tether strap being used during the incident.If the tether failsafe device were used as directed, it would have mitigated the risk and prevented the seating system from falling to the ground.During the incident, the end user reportedly landed on his head and was subsequently evaluated by his pediatrician.The end user allegedly sustained bruising and a non-descriptive head injury.There was no information provided regarding diagnosis or treatment.The mother reports that the user will be okay.Conclusion: in conclusion, based on the information provided, inadequate attachment of the seat to the stroller base potentially led to the detachment of the seat, as well as a failure to use the included tether failsafe device to prevent injury.This device is used for treatment, not diagnosis.While there is limited information on the incident and the reported injuries sustained, due to the allegation of a potential severe injury (head injury), this mdr is being filed.
Event or Problem Description
A voluntary medwatch report (mw5149183) was received detailing an incident involving a zippie voyage wheelchair where the seat became detached from the base and flipped upside down.The end user reportedly landed on his head.The end user allegedly sustained bruising and a non-descriptive head injury.There was no information provided regarding diagnosis or treatment.

• Brand Name: ZIPPIE
• Common Device Name: EARLY INTERVENTION STROLLER
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL TECNOLOGIAS S.A. DE CV; privada misiones no. 110; parque industrial misiones; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18619206
• Report Number: 9616084-2024-00001
• Device Sequence Number: 19434420
• Product Code: INM
• UDI-Device Identifier: 00016958053647
• UDI-Public: 00016958053647
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ZIPPIE VOYAGE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male