MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-22 for ZIPPIE VOYAGE EIZ14 manufactured by Sunrise Medical Privada Misiones.
[103216024]
Sunrise medical has requested with the dealer that the stroller be returned for a full evaluation. The stroller has the slide-n-lock base in which the seating system will slide onto the base and lock into place. The seating system is successfully locked into place when an audible click is heard. In a past evaluation it was found that if there is an obstruction of any type between the seating and the slide-n-lock systems, that interference will not allow them to lock and the locking click will not be heard. A replacement stroller base shipped to the dealer on 3/15/18. However, we have not received the original stroller base for evaluation. It is currently unknown what the actual root cause of the failure is since an evaluation has not been performed. Further detail about the incident and the child's condition was requested from the family, however we have not received a response. The family also alleged that their child received a mild concussion but that has not been confirmed by a medical examiner. If new information is provided by the family and we receive the stroller for evaluation, a supplemental report will be filed with any relevant information.
Patient Sequence No: 1, Text Type: N, H10
[103216025]
Sunrise medical sales representative, peter grams received a report that the chair base and seating became unexpectedly disconnected from each other. The child fell forward from the elevated position and smacked his head on the ground. Reported a mild concussion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00002 |
| MDR Report Key | 7362629 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-22 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-03-22 |
| 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 |
| Reporter Occupation | OCCUPATIONAL THERAPIST |
| 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 | 3 |
| Brand Name | ZIPPIE VOYAGE |
| Generic Name | STROLLER (CHAIR WITH CASTERS) |
| Product Code | INM |
| Date Received | 2018-03-22 |
| Returned To Mfg | 2018-05-08 |
| Model Number | EIZ14 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Life Threatening | 2018-03-22 |