MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-15 for ZIPPIE VOYAGE EIZ4 manufactured by Sunrise Medical Privada Misiones.
[82938132]
Sunrise medical has requested from the dealer the return of the stroller for a full evaluation. Unable to determine at this time if a malfunction occurred or if the product is defective. A new replacement stroller was provided and delivered to the dealer on (b)(6) 2017. Once the original stroller is received by sunrise medical, a full evaluation will be performed, followed by a supplemental report with any relevant findings.
Patient Sequence No: 1, Text Type: N, H10
[82938133]
Per dealer, (b)(6) the seating system fell off the base twice while the parents were walking outside with the end user in the stroller. The seat fell into the storage below and did not hit the ground. The family states that they were unsure if it was the latches the first time but made sure it was prior to the second. Dealer states that there is no visible damage. The family also stated that it only occurred while the seat was in the reverse position. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2017-00004 |
| MDR Report Key | 6796140 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-15 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2016-04-21 |
| Date Added to Maude | 2017-08-15 |
| 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 | LBE |
| Date Received | 2017-08-15 |
| Returned To Mfg | 2017-09-28 |
| Model Number | EIZ4 |
| 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 | 2017-08-15 |