MAUDE Adverse Event Report: ZIPPIE VOYAGE; EARLY INTERVENTION STROLLER

Model Number	ZIPPIE VOYAGE
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Background information: please reference zippie voyage recall (res# (b)(4)) regarding new remediation for this issue.This mdr is being filed due to severity of potential injury and updated risk file for this failure mode.While there is no design, manufacturing, or assembly malfunction, there is a known potential malfunction on the part of the caregiver when not adequately attaching the detachable seat from the early intervention stroller.Full details of the voluntary field safety notice are filed within sunrise medical recall file 2937137-6/28/21-001-c.Father stated that he did not have tether installed.Father stated that he did not know who last attached the seat to base or when, or if anyone touched or moved the seat or base during the child's therapy appointment.Discussion: root cause of the reported incident is most likely due to the caregiver inadequately attaching the detachable stroller seat to the stroller base or inadequately checking to make sure the detachable seat was still attached following the child's therapy appointment.This detachable configuration is a user requirement (market requirement).There is no malfunction of the stroller base, but due to the nature of the potential injury for serious injury or death, this issue is being filed although there is no malfunction of the device.The issue may be the result of lack of a failsafe device such as the voyage safety tether kit which will be sent out to all device owners as part of the aforementioned recall.Conclusion: while there is no malfunction of the device leading to the fall, due to the unexpected detachment and lack of a failsafe device, this mdr is being filed.The voyage 2021 recall addresses the remediation of this device.No further investigation will be performed in this case.
Event or Problem Description
Father of end user was descending a ramp at the doctor's office when the voyage seat unexpectedly slid off the base.The child fell to the ground and suffered a head injury reported as bruising.Follow-up medical exam including head ct scan did not reveal any other injuries.

• Brand Name: ZIPPIE VOYAGE
• Common Device Name: EARLY INTERVENTION STROLLER
• MDR Report Key: 12657330
• Report Number: 9616084-2021-00062
• Device Sequence Number: 4852441
• Product Code: INM
• UDI-Device Identifier: 00016958053647
• UDI-Public: (01)00016958053647(12)ZV18-000751
• Combination Product (Y/N): N
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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
• Device Catalogue Number: EIZ18
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 88257
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 14