MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-23 for QUICKIE IRIS EIZ4-2 manufactured by Sunrise Medical Privada Misiones.
[142813148]
Sunrise medical's regulatory team reviewed the letter of complaint sent to our legal team. For reporting purposes and this being a legal case, the end user's name was replaced with "plaintiff". It is unclear as to what the root cause for the alleged rear wheel failure was that led to the end user falling from his chair. The letter does state: "... The left wheel of his chair became detached from the body of the chair, causing (plaintiff) to pitch forward and down, out of the chair... ". Since the wheels are designed for quick removal by the end-user, one likely cause for failure is that the wheels were not properly mounted on the chair. Other contributors include bumping the chair's wheels against walls, doors, etc. , which could cause the wheel axle to become damaged and lead to the failure. Improper adjustments to the axle and improper cleaning of the axles could also contribute to the wheel not engaging properly and eventually falling off. However, since the subject wheelchair and its components have not been made available to sunrise medical personnel for inspection and evaluation, sunrise medical is unable to determine the actual cause for the allegation. Page 12, section j. Quick-release axles, of the applicable wheelchair's owner's manual states: "do not use this chair unless you are sure that both quick-release rear axles are locked. " "an axle is not locked until the quick-release button pops out fully. If the axle is not inserted fully, the wheel may come off during use, endangering the rider. " "quick-release axles should be periodically cleaned and inspected for function, and signs of wear or bending. Replace as necessary. If you fail to heed these warnings, damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others. " since the subject wheelchair has not been made accessible by the complainant or complainant's attorney, sunrise medical is unable to perform a physical inspection and determine the actual cause for the customer's allegation. If and when sunrise medical is provided any new relevant information or access to the wheelchair for evaluation, a follow up report may be filed.
Patient Sequence No: 1, Text Type: N, H10
[142813149]
A legal notice from the law offices of (b)(6) law, dated and received by sunrise medical (us) llc on (b)(6) 2019 states, "(plaintiff) was at his home being attended to by his full-time caregiver, when he used the new chair to move from his bed in order to retrieve a video game controller which was less than six feet away. As he moved, the left wheel of his chair became detached from the body of the chair, causing (plaintiff) to pitch forward and down, out of the chair, and into the wall. (plaintiff) suffered a broken arm and a head injury when his chair fell apart... "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2019-00004 |
| MDR Report Key | 8541043 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2019-04-23 |
| 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 | QUICKIE IRIS |
| Generic Name | MANUAL WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-04-23 |
| Model Number | EIZ4-2 |
| Operator | LAY USER/PATIENT |
| 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; 2. Required No Informationntervention | 2019-04-23 |