MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-01-11 for RELIANCE MODEL DMI 230 230 DMI manufactured by .
[1784376]
Health professional's impression as described on (b)(4) hospital report (b)(4): title: xxxxx. Event desc: recently, reliance procedure chairs were installed in a dermatology practice office affiliated with our facility. Approx 16 days later, a pt was sitting in the chair to undergo biopsy/excision of an 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.
Patient Sequence No: 1, Text Type: D, B5
[8944294]
I spoke with the clinical risk mgr at (b)(6) hospital. (b)(6) stated that the chair was purchased from a refurbishment facility in (b)(4). Reliance medical products is in no way associated with (b)(4). (b)(4) is not an approved source for refurbishing of any of our products. Due to not having access to the suspect product, a proper eval cannot occur for method, results, conclusion as requested. Reliance medical products post market surveillance data indicates no complaints pertaining to the type of failure reported. Reliance medical products ceased production and shipment of this model in 2005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523545-2011-00001 |
| MDR Report Key | 1962617 |
| Report Source | 06 |
| Date Received | 2011-01-11 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-17 |
| Report Date | 2010-11-01 |
| Date Reported to FDA | 2010-11-01 |
| Date Mfgr Received | 2010-12-09 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2011-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RUSSELL WOLFE |
| Manufacturer Street | 3535 KINGS MILLS RD. |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5133983937 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE MODEL DMI 230 |
| Generic Name | RELIANCE 230 DMI |
| Product Code | HME |
| Date Received | 2011-01-11 |
| Model Number | 230 DMI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-11 |