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

Model Number	ZV18
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Background information: please reference zippie voyage recall (res# 88257) 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.Zippie voyage owner manual (245797, rev.B, section viii: use & maintenance, page 15, section i: seating installation) states "using the latch lock: a.Before attaching or removing the seat to or from the base, the latch lock (k) must be slid to the right (unlocked position) as shown in fig 14.B.To prevent inadvertent activation of the seat latch, slide the latch lock to the left as shown in fig 15 after the seat is fully secured to the base (you cannot attach seat to base while lock is engaged)." and "b.Ensure all positioning straps and accessories are out of the way and will not interfere with the seat from fully engaging the receiver." risk analysis (ufmea early intervention strollers master, risk id 73) lists "seat system detaches from stroller base when in use" as a known failure mode.Unmitigated risk is scored as "unacceptable." mitigated risk (addition of safety tether) is scored as "acceptable." discussion: based on the dealer's description of the incidents, root cause of the reported incidents is most likely due to the caregiver inadequately attaching the detachable stroller seat, potentially due to foreign object interference.There is no confirmation of latch malfunction or malfunction of the stroller base through dealer investigation or user report.This detachable configuration is a user requirement (market requirement).The issue is most likely due to the lack of a failsafe device such as the voyage safety tether kit which is being sent out to all device owners as part of the aforementioned recall.Conclusion: while there may or may not be a malfunction of the device leading to the seat detachment, 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 as the cause is ultimately the lack of a failsafe device which is being actively remediated.
Event or Problem Description
The caregiver describes three separate incidents, dates unspecified, where the stroller seat fell from the stroller base.The last incident, the dealer reports that the seating system "did not latch and fell off the base without the child in the chair." also, "dealer thinks it is a latch failure or strap issue;" however, latch was not tested and, if inspection was performed, it was not documented.Also, product was not returned to the manufacturer for testing.The caregiver, after the third incident, stopped using the stroller.No injuries are reported.

• Brand Name: ZIPPIE VOYAGE
• 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 (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 12921129
• Report Number: 9616084-2021-00065
• Device Sequence Number: 5111927
• Product Code: INM
• UDI-Device Identifier: 00016958053647
• UDI-Public: (01)00016958053647(12)ZV18-000980
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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
• Device Model Number: ZV18
• Device Catalogue Number: EIZ18
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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
• Patient Sex: Unknown
• Patient Weight: 9 KG