MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-23 for DMI RELIANCE MODEL 230 DMI 230DMI * manufactured by Reliance Medical Product, Inc..
[1679285]
Recently reliance procedure chairs were installed in a dermatology practice office affliated with our facility. Approximately 16 days later, a patient was sitting in the chair to undergo biopsy/excision of a ear lesion. Prior to excision the chair and patient abruptly fell from the elevated position to the floor. The patient did not fall off of the chair, but the chair did abruptly hit the ground. A yellow colored fluid (presumed to be hydraulic fluid) began leaking from the chair. The patient suffered no apparent injury. The vendor was notified and will be sending service technicians to evaluate and repair the equipment. ====================== health professional's impression======================the failure of the chairs hydraulic system could cause the patient to hit the floor abruptly, be ejected from the chair, or could have been injured had the biopsy procedure been underway. This could have also resulting in harm to the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1928870 |
| MDR Report Key | 1928870 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-11-17 |
| Report Date | 2010-11-23 |
| Date Reported to FDA | 2010-11-23 |
| Date Added to Maude | 2010-12-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DMI RELIANCE MODEL 230 DMI |
| Generic Name | RELIANCE CHAIR |
| Product Code | HME |
| Date Received | 2010-11-23 |
| Model Number | 230DMI |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL PRODUCT, INC. |
| Manufacturer Address | 3535 KINGS MILLS RD. MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-23 |