MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-09-18 for LUMEX DIALYSIS CHAIR manufactured by Graham Field Health Products.
[964470]
Chair cable broke while pt was sitting in chair. Back of chair collapsed backward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1172803 |
| MDR Report Key | 1172803 |
| Report Source | 99 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-09-18 |
| Date of Event | 2008-08-13 |
| Date Facility Aware | 2008-08-13 |
| Report Date | 2008-09-18 |
| Date Reported to Mfgr | 2008-09-18 |
| Date Added to Maude | 2008-10-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEX DIALYSIS CHAIR |
| Generic Name | DIALYSIS CHAIR |
| Product Code | FKS |
| Date Received | 2008-09-18 |
| Model Number | LUMEX |
| Lot Number | 71707605910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1209498 |
| Manufacturer | GRAHAM FIELD HEALTH PRODUCTS |
| Manufacturer Address | 2935 NORTHEAST PARKWAY ATLANTA GA 30360 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-18 |