MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for ZIPPIE VOYAGE EIZ16 manufactured by Sunrise Medical Privada Misiones.
[127366375]
On 10/18/18 sunrise medical gathered additional information from account manager (b)(6). He stated the technician at the facility had to use blue lock tight tape to keep screws from falling out. (b)(6) was unable to determine and is currently unknown which failed hardware may have caused or contributed to the seating system falling off of the base. (b)(6) did confirm that the child did receive a bloody nose and a golf ball size goose-egg bump on his forehead. After going to the hospital, it was recommended to take the child to a pediatrician. The child was taken to the pediatrician and all checked out okay. There was no follow up appointment needed but it was recommended to watch him for any change in his condition. (b)(6) said he did see him that following thursday and the child does have a bump on his forehead; however, it appeared that he was doing well. The subject stroller was researched by sunrise medical's regulatory department and it was found that there is no history of a similar incident occurring since the stroller's manufacture and ship date of 1/4/2017. It was requested that the dealer return the stroller for a full evaluation; however, sunrise medical has not received the stroller despite numerous attempts. The failure as described in this report/complaint is a known risk and has been addressed in the products ufmea stating the potential cause of failure to be improper torque adjustment of the hardware. The current controls is listed as, "all torque settings are included and min torque is included in the owner's manual. Service is only to be done by an authorized dealer". The risk evaluation score is at 9 which is equal to: corrective action is not required, but may be assessed to lower risk even further if agreed upon by design team or management. Although the injury is not considered serious as described in part 803 of the fda standard and the failure was not likely due to a malfunction or defect, sunrise medical has decided to file this mdr out of an abundance of caution. If and when the parts are returned for evaluation, a supplemental report will be filed. No further investigation will be performed by sunrise medical at this time.
Patient Sequence No: 1, Text Type: N, H10
[127366376]
Sunrise medical account manager (b)(6) reported that the locking system for the base plate had 3 screws work themselves loose as well as screws from the bottom of the plate. The mother was rounding the corner to enter the bathroom and the seating systems fell off the base onto the floor. Medical attention was provided. The child had a bump on his head and a bloody nose. He was seen by the hospital staff and then he was sent to see his primary doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00011 |
| MDR Report Key | 8070465 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2017-01-04 |
| Date Added to Maude | 2018-11-14 |
| 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 | 0 |
| Brand Name | ZIPPIE VOYAGE |
| Generic Name | STROLLER (CHAIR WITH CASTERS) |
| Product Code | INM |
| Date Received | 2018-11-14 |
| Returned To Mfg | 2019-05-22 |
| Model Number | EIZ16 |
| 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 PRIVADA INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |