MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for LUMEX EXTRA-WIDE CLINICAL CARE RECLINER 587W-KIT MC587W8584 manufactured by High Spot Health Technology Co., Ltd..
[51497186]
Patient Sequence No: 1, Text Type: N, H10
[51497187]
The casters (wheel) locking mechanism break easily due to being plastic. Once these break the chair is unable to be in a stationary mode and will move during attempts to sit or rise into/from the chair posing a fall risk. Additionally, the foot rest is only able to fully be retracted (parked) if the wheels are aligned perfectly forward. Need to have the footrest fully "parked" prior to entry/exit of the chair for patient safety or patients have been known to cut their ankles, also causes staff to use force lending to staff injury, patient injury and tearing of the footrest fabric requiring repeated repair. Reclining is weight based and shifting in chair can cause the chair to unexpectedly snap into upright position, staff are using other chairs to prop the foot rest on to assure that this cannot happen to avoid patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856184 |
| MDR Report Key | 5856184 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-01 |
| Report Date | 2016-08-01 |
| Date Reported to FDA | 2016-08-01 |
| Date Reported to Mfgr | 2016-08-01 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 EXTRA-WIDE CLINICAL CARE RECLINER |
| Generic Name | CHAIR, ADJUSTABLE, MECHANICAL |
| Product Code | INM |
| Date Received | 2016-08-09 |
| Model Number | 587W-KIT |
| Catalog Number | MC587W8584 |
| Operator | NURSE |
| Device Availability | Y |
| 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 | 1. Other | 2016-08-09 |