MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for QUICKIE GT EIR3 manufactured by Sunrise Medical (us) Llc.
[139163485]
On (b)(6) 2019, sunrise medical customer service contacted (b)(6) to gather additional information regarding this incident. (b)(6) was able to speak with the end user and stated that the end user alleges the incident occurred two weeks prior. He says he was in the chair tending to his daily activities when all of the sudden the wheel rim popped and 8 or 9 spokes went flying off. He claims that one of the spokes struck him in the arm, causing an injury that required stitches. He also stated that he did not keep the wheel because he felt it was too dangerous to have laying around, so he threw it out. Sunrise medical regulatory researched the history of the subject wheelchair and found no record of the chair ever being serviced since its manufacture date of 6/19/14. Sunrise medical's quality engineer reported that the same spoke wheel is used on several quickie manual wheelchairs and there has not been a failure mode of this magnitude ever being recorded in the past and that it is highly unlikely that this failure occurred due to a malfunction or deficiency in the product. It is likely, however, that the failure occurred due to a lack of maintenance or abuse of the chair since so many spokes came loose at the same time. It is stated in the maintenance chart, located on page 14 of the quickie gt owner's manual to check the wheels, tires and spokes every 3 months. It also states in the troubleshooting chart in the owner's manual: make sure all spokes and nipples are tight on radial spoke wheels. Since the end user has thrown away the wheels, sunrise medical is unable to perform a thorough inspection and evaluation of the product and therefore is unable to verify and validate the end user's claim. However, as a courtesy to the end user and as a good customer service practice, sunrise medical has decided to accommodate the end user with a replacement wheel even though he has not provided any proof of his claim. No further investigation will be performed by sunrise medical at this time.
Patient Sequence No: 1, Text Type: N, H10
[139163486]
Dealer, (b)(6), reported on (b)(6) 2019 per her client, the spokes on the rim allegedly "blew off" and one went into the client's arm which caused him to have stiches in his arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937137-2019-00008 |
| MDR Report Key | 8430599 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2019-03-18 |
| 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 |
| Manufacturer G1 | SUNRISE MEDICAL (US) LLC |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUICKIE GT |
| Generic Name | MANUAL WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-03-18 |
| Model Number | EIR3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL (US) LLC |
| Manufacturer Address | 2842 BUSINESS PARK AVE. FRESNO CA 93727 US 93727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-18 |