MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-22 for ZIPPIE VOYAGE EIZ14 manufactured by Sunrise Medical Privada Misiones.
[112053147]
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.
Patient Sequence No: 1, Text Type: N, H10
[112053148]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00007 |
| MDR Report Key | 7630194 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-22 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-06-22 |
| 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 |
| 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 | 2018-06-22 |
| Returned To Mfg | 2018-09-18 |
| Model Number | EIZ14 |
| 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. Hospitalization | 2018-06-22 |