MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-19 for ZIPPIE VOYAGE EIZ14 manufactured by Sunrise Medical Privada Misiones.
[112448362]
Sunrise medical's sales rep, (b)(6) spoke with the child's mother at 4:05pm on (b)(6) 2018. She did confirm that the seating system did fall off of the base. She stated the extent of the injuries were a "goose egg" bump and some "scrapes", this was determined when she admitted her child to the er for evaluation. There were no other injuries. The mother also stated that she was not sure if the seating system was properly locked onto the base when the incident occurred. At this time, sunrise medical is unable to determine if a malfunction occurred. A similar instance has occurred previously, in where the seating system was not properly attached to the base that resulted in the seat falling off of the base and no malfunction or defect was found after inspecting the stroller. (b)(6) a dme at all saints home medical, which sold her the stroller, performed an inspection of the stroller and called sunrise medical on (b)(6) 2018 with his findings. (b)(6) states he found no malfunction or defects with the product. The seating system properly locks onto the base with an audible click indicating the seating and base locked together properly. He performed a stress test, rocking the seating system but was not able to duplicate the failure. In accordance with title 21cfr 820. 198(b) no further investigation will be made by sunrise medical due to a similar incident where a complaint analysis was performed when a previous complaint was received. Sunrise medical's quality engineer performed an evaluation on (b)(6) 2018 of a similar product with the same failure claim. It was found that the failure could not be duplicated, however, a possible root cause could be interference from the seating system's harness straps. If the straps are not cleared out of the way, they could obstruct the seating system from properly locking into place. Therefore, an additional analysis will not be performed as the previous investigation was for the same cause as the current complaint. It is stated in the zippie voyage owner's manual on page 14, section i. Seating installation, install the seating shell, point b, c, d and e: ensure all positioning straps and accessories are out of the way and will not interfere with the seat from fully engaging the receiver. Line up the alignment tag with the support cross bar on the base. Lower the seating shell so that the seating shell and mounting plate are in contact. 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. Currently, the stroller is not in use, the child is in another chair. Sam goth will return the stroller to sunrise medical.
Patient Sequence No: 1, Text Type: N, H10
[112448363]
Patient's mother called to report on (b)(6) the child's teacher was pushing the patient to the bus. The patient began to rock back and forth when the top half of the zippie voyage came detached from the base. The patient fell out of the stroller and landed on his head and received a large cut. He was taken to the emergency room for evaluation but no other injuries noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00006 |
| MDR Report Key | 7617606 |
| Date Received | 2018-06-19 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-05-24 |
| Device Manufacturer Date | 2017-08-29 |
| Date Added to Maude | 2018-06-19 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | INM |
| Date Received | 2018-06-19 |
| Model Number | EIZ14 |
| Operator | OTHER CAREGIVERS |
| 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 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-19 |