MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for CAREX TRANSPORT CHAIR FGA22600 0000 A226-00 manufactured by Maxhealth Corp..
[68465219]
The end-user was sitting in the wheelchair (transport chair), shopping at a grocery store, when she had a heart attack. She leaned back in the wheelchair, and the upper bars snapped in half - she landed on the back of her head and broke her head open. She was taken to the hospital, and spent two weeks there, healing from the heart attack and head wound. The end-user was reported as being in the grocery store with her friend at the time of the event. Her friend went to go get carrots, which left the end-user alone for a few minutes. The end-user had the heart attack, and, again, fell back and hit her head, causing her to need 5 stitches. She is reported as doing ok. The device was returned to compass health brands on 2/13/2017, and its composite aluminum bars were found to have cracked/broken just above the lever to fold the backrest down - as a result, the backrest can no longer secure in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00018 |
| MDR Report Key | 6362694 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-27 |
| Date of Event | 2016-10-06 |
| Date Facility Aware | 2017-02-01 |
| Report Date | 2017-02-27 |
| Date Reported to FDA | 2017-02-27 |
| Date Reported to Mfgr | 2017-02-27 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREX TRANSPORT CHAIR |
| Generic Name | TRANSPORT CHAIR |
| Product Code | KNN |
| Date Received | 2017-02-27 |
| Model Number | FGA22600 0000 |
| Catalog Number | A226-00 |
| Lot Number | N/A |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXHEALTH CORP. |
| Manufacturer Address | 15F-6, NO. 81, SEC. 1, HSIN TAI WU ROAD, HSI CHIH TAIPEI HSIEN, TAIWAN 221 TW 221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-27 |