MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-20 for MULTI JOINT SYSTEM 820-100 manufactured by Biodex Medical Systems.
[8597]
Welds in seat base, back support, and headrest are cracking. Used for stress testing, only 2 years old. Danger exists if force is applied to unit. Rptr have welded the unit to repair and add extra support, because mfr would not replace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000137 |
| MDR Report Key | 10560 |
| Date Received | 1993-12-20 |
| Date of Report | 1993-12-14 |
| Date of Event | 1993-12-08 |
| Date Added to Maude | 1993-12-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI JOINT SYSTEM |
| Generic Name | MULTI JOINT SYSTEM |
| Product Code | IMS |
| Date Received | 1993-12-20 |
| Model Number | 820-100 |
| Device Expiration Date | 1992-11-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10560 |
| Manufacturer | BIODEX MEDICAL SYSTEMS |
| Manufacturer Address | SHIRLEY NY 119670198 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Not Applicable; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 1993-12-20 |