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

Model Number	ZIPPIE VOYAGE VIP
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
The dealer describes an incident that occurred where a "boy fell out of the chair" and received a cut to the forehead that required 8 stitches to close.No other description of the incident was provided.
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.Caregiver 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: the description of the incident does not refer to any issue relating to the latching or attachment or detachment of the seat to the stroller base, but only refers to a fall out of the chair.A fall may occur in other circumstances, including those relating to user error.There is no confirmation of latch malfunction or malfunction of the stroller base through dealer investigation or user report.The mother does describe injuries that did require medical attention (stitches).Conclusion: while there may or may not be a malfunction of the device leading to falling out of the chair, due to the report of stitches and in an abundance of caution, this mdr is being filed.The voyage 2021 recall addresses the remediation of this device to the extent the fall out of the chair is related to seat detachment.

• Brand Name: ZIPPIE
• Common Device Name: VOYAGE
• 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: 13028476
• Report Number: 9616084-2021-00070
• Device Sequence Number: 19286786
• Product Code: INM
• UDI-Device Identifier: 00016958053647
• UDI-Public: (01)00016958053647(12)ZV18-001632
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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 VIP
• Device Catalogue Number: EIZ18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/17/2021
• 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: 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: Required Intervention
• Patient Sex: Male