MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES ZIPPIE VOYAGE; STROLLER (CHAIR WITH CASTERS)

Model Number EIZ14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Vomiting (2144)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Sunrise medical's sales representative, (b)(4), which is working with the dealer on this incident, reported on (b)(6) 2018 that the child was admitted to the hospital per the neurologists request and is being monitored for a concussion.It is unknown at this time what the root cause of the failure is, as the dealer is still in the process of performing an evaluation of the stroller.Sales representative, (b)(4) is staying in contact with the dealer to report any new information.At the time of this filing, there have been no new requests for replacement parts or replacement of the stroller.Upon receiving any new relevant information from the evaluation, a follow up report will be filed.

Event Description

On (b)(6) 2018, mother was pushing her child in his stroller and turned to take him into the bathroom and as she turned he fell off the base.This happened at the (b)(6) hospital.Sunrise medical sales representative, (b)(4), stated child started vomiting and the neurologist advised the mother to take him to the er to have him checked out.

Event Description

Please see initial mdr 9616084-2018-00007.

Manufacturer Narrative

Sunrise medical received the zippie voyage, serial number (b)(4) on 9/18/18 for a full evaluation.Sunrise medical's r&d engineer performed the evaluation on 9/21/18.The following was observed from the evaluation: "upon removing the seating system from the slide-n-lock base, it was noted that one of the flat head screws (fhcs) on the base plate was replaced with a non-sunrise medical authorized button head cap screw (bhcs).The head of the bhcs sits raised above the base plate and not flush to the mounting plate as the fhcs was designed to do.The taller head of the bhcs prevents the seating system from sitting flush against the base plate making it difficult to latch and unlatch the seating system.Evidence of this interference can be seen in the form of visual scrape marks on the underpart of the seating system.Also, the bhcs was longer than the original fhcs.This added length causes the bolt to interfere with the base plate mounting bar making it impossible to rotate the plate as per the original design intent.In addition to the use of the bhcs it was observed that the tilt plate orientation was not properly adjusted causing the seating system to tilt forward rather than backward.It is of the opinion of the r&d engineer that the use of the non-sunrise medical authorized bhcs likely caused the seating system to not latch properly onto the base which in turn led to the seating system becoming dislodged from the base.The misadjusted tilt plate orientation may have contributed to the issue by allowing the seat to tilt forward thereby allowing it to slide out of the securement brackets.These two observations are changes and adjustments that were done in the field and are not to sunrise medical specification.It is concluded that with the exception of those two observations, the zippie voyage was found to perform to specification and no malfunction or defect was found." this concludes the evaluation report as provided by sunrise medical's r&d engineer.Since the initial mdr was filed on 6/22/18, the original stroller has been replaced.A new stroller was shipped to the end user's dealer on 7/5/18.No further investigation will be performed by sunrise medical.

• Brand Name: ZIPPIE VOYAGE
• Type of Device: STROLLER (CHAIR WITH CASTERS)
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• MDR Report Key: 7630194
• MDR Text Key: 112053147
• Report Number: 9616084-2018-00007
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIZ14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR
• Patient Weight: 10