MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for ZIPPIE VOYAGE EIZ16 manufactured by Sunrise Medical Privada Misiones.
[145484687]
This is a known issue with the zippie voyage seating system. In investigating past incidents, sunrise medical's quality investigators and r&d engineers have found that there were several factors for such a failure as: improper mounting of the seating system by the care provider, where an audible click is heard when the seat is properly latched to the base. After market hardware used on the latching system which did not sit flush to the base, therefore causing the seat to not latch properly. Straps on the seat back system were not cleared out of the way when the seat was mounted on the base and obstructed the latch from connecting properly. Sunrise medical has made arrangements to have the stroller returned for a full evaluation. A follow up report may be filed to include any new relevant findings from the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145484688]
The mother of an end user reported to sunrise medical via email an adverse event involving her son and a zippie voyage stroller. The mother claims the seat unlatched from the base while her son was in the seat and fell to the ground. She states he was taken to the hospital and claims that he received a "closed head injury" per the doctor's diagnosis. She stated the doctor didn't feel that a ct-scan was necessary and the end user was released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2019-00005 |
| MDR Report Key | 8621667 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2018-09-18 |
| Date Added to Maude | 2019-05-17 |
| 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 |
| 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 | INM |
| Date Received | 2019-05-17 |
| Model Number | EIZ16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL PRIVADA MISIONES |
| Manufacturer Address | NO. 110 PRIVADA INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-05-17 |