MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for ZIPPIE VOYAGE EIZ4 manufactured by Sunrise Medical Privada Misiones.
[89937846]
Stroller was received by sunrise medical and inspected by lead engineer manual r&d on 10/3/2017. The original seating system was not returned with the stroller base, however the parent did indicate in the complaint that the latch mechanism was not broken. However, upon review of the returned base, it was evident that the rotational lock on the slide-n-lock mounting plate was not functioning properly. This issue does not appear to be related to the report of "catapulting" but it may be indicative of loading that could have damaged the latch system even if the parent did not notice the failure. Because the seating system was not returned with the base the evaluation was conducted with a seating system similar to the one that would have been shipped with the chair. During the investigation, when the seat was mounted and the red locking mechanism was properly engaged, the seat was secure and there was no potential for "catapulting" when the seat was brought back to its upright position from the tilt position. To determine if incorrect installation of the seating system could contribute to the described failure, a test was conducted by activating the latch lock system prior to installing the seat. This allows the seat to sit on the slide-n-lock plate but prevents the latch mechanism from engaging. In this condition the failure mode as described in the complaint was able to be repeated. The potential for failure will be dictated by the effectiveness of the seat latch and by the fore/aft loading of the seat. Instructions for installation of the seating shell are explained in section "i", point "e" of the third paragraph of the sunrise medical, zippie voyage owner's manual, titled "install the seating shell" which states, "slide the seat backwards evenly. You should hear an audible click. Check the secure engagement to the base by pulling up on both sides. If it does not move or tilt, the seating shell is now locked and has been installed properly. " sunrise medical has determined that a similar event is unlikely to occur when these installation steps are taken.
Patient Sequence No: 1, Text Type: N, H10
[89937847]
Per (b)(4), the end user's mother states they launched and moved the red lever and went backwards from the steps, when they turned around the whole seating system "catapulted" off of the base of the chair and the child fell directly on their head. The child was taken to the er as a precaution and the doctor did an initial evaluation. Per sales rep (b)(4) he was told that the doctor did not feel there was anything wrong with the child as the child was playing around and playing on an (b)(6). (b)(4) stated that the parents did do a few tests on the stroller. They attempted to pull the chair hard to see if they would be able to pull the seating off and said that it was not moving. The father stated he made sure that the latch mechanism was not broken. He states that the shoulder straps hang down pretty far and is not sure if they possibly caused interference when putting system in to place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2017-00009 |
| MDR Report Key | 6918672 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2017-08-09 |
| Date Added to Maude | 2017-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIPPIE VOYAGE |
| Generic Name | STROLLER (CHAIR WITH CASTERS) |
| Product Code | LBE |
| Date Received | 2017-10-05 |
| Returned To Mfg | 2017-09-26 |
| Model Number | EIZ4 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL PRIVADA MISIONES |
| Manufacturer Address | NO. 110 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |