MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-23 for QUICKIE Q500M EIPW30 manufactured by Sunrise Medical (us) Llc.
[176206158]
On (b)(6) 2020 sunrise medical regulatory followed up with (b)(6) in an attempt to gather additional information regarding the house fire. (b)(6) stated the end user was in hospice care at the time, but there was no additional information regarding the fire. (b)(6) said the fire report has not been released as this is still an ongoing investigation. It is currently unknown if the end user was in the wheelchair at the time of the fire or if the chair had anything to do with the fire at all. (b)(6) is not sure if the ongoing investigation is being performed by the fire department or another investigative agency. This was all the information the dealer could provide at this time. Although the root cause of the fire is unknown and there was no previous report of a malfunction or defect made against the wheelchair, sunrise medical has decided to file the mdr due to a death being involved. If and when additional relevant information is provided from the investigation, a follow up report may be submitted by sunrise medical. No further investigation will be performed by sunrise medical at this time.
Patient Sequence No: 1, Text Type: N, H10
[176206159]
Per dealer, (b)(6), on (b)(6) 2019 the end users home caught on fire. The end user passed away on (b)(6) 2019 as a result of the fire. The wheelchair was also damaged in the fire. The cause of the fire is under investigation and the chair will not be released. Per (b)(6), monroe wheelchair had not been contacted for any service calls or repairs for this chair prior to the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937137-2020-00005 |
| MDR Report Key | 9624841 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | QUICKIE Q500M |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-01-23 |
| Model Number | EIPW30 |
| 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. Death | 2020-01-23 |