MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-13 for LUMEX DIALYSIS CHAIR manufactured by Lumex.
[16298298]
Facility alleged chair flipped backwards while occupied. Rn reported chair was in trendelenburg, pt moved and chair flipped over backwards, causing pt to bump head. No further injury reported; pt stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00646 |
| MDR Report Key | 25850 |
| Date Received | 1995-08-13 |
| Date of Report | 1995-07-18 |
| Date of Event | 1995-05-19 |
| Date Facility Aware | 1995-07-14 |
| Report Date | 1995-07-18 |
| Date Reported to FDA | 1995-07-18 |
| Date Reported to Mfgr | 1995-07-18 |
| Date Added to Maude | 1995-09-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEX DIALYSIS CHAIR |
| Generic Name | DIALYSIS CHAIR |
| Product Code | FKS |
| Date Received | 1995-08-13 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26493 |
| Manufacturer | LUMEX |
| Manufacturer Address | 100 SPEULE ST BAUSHORE NY 11706 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-13 |