MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for LUMEX RECLINER X WIDE FR587W 2867FR587W manufactured by High Spot Health Technology Co., Ltd..
[26447658]
Patient Sequence No: 1, Text Type: N, H10
[26447659]
Recliner chairs made specifically for hospital use for proper patient positioning continue to tear on the foot rest due to design and catching on the wheel base. This tear becomes an infection risk and requires constant replacement of fabric to assure patient safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5093880 |
| MDR Report Key | 5093880 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-09-01 |
| Report Date | 2015-09-16 |
| Date Reported to FDA | 2015-09-16 |
| Date Reported to Mfgr | 2015-09-16 |
| Date Added to Maude | 2015-09-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEX RECLINER X WIDE FR587W |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | BYN |
| Date Received | 2015-09-22 |
| Model Number | 2867FR587W |
| Catalog Number | FR587W |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HIGH SPOT HEALTH TECHNOLOGY CO., LTD. |
| Manufacturer Address | 2064 TAMARIN DR COLUMBUS OH 43235 US 43235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-22 |