MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for RELIANCE MEDICAL PRODUCTS FX920 LOW VOLTAGE CONTROL CHAIR NOT APPLICABLE manufactured by Reliance Medical Products, Inc..
[87659721]
No injury has been reported with this concern at this time. Further follow-up will be performed as necessary.
Patient Sequence No: 1, Text Type: N, H10
[87659722]
Dealer representative (b)(6) reports that after performing a laser procedure, the operator hit the auto switch button to have the unit return to the home position. On the way up the chair tipped and fell backwards. The patient, male, of average build and perhaps his age is in his 50's was not harmed and neither was the doctor. She (doctor) reported it touched her knee but was able to get out of the way of the tipped chair. The chair was at a 90 degrees when this incident happened. Also, the headrest on the chair was damaged. This chair is located at (b)(6) university.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523545-2017-00001 |
| MDR Report Key | 6892373 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-09-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK BEISMANN |
| Manufacturer Street | 3535 KINGS MILLS ROAD |
| Manufacturer City | MASON OH 450402303 |
| Manufacturer Country | US |
| Manufacturer Postal | 450402303 |
| Manufacturer Phone | 5133983937 |
| Manufacturer G1 | RELIANCE MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 3535 KINGS MILLS ROAD |
| Manufacturer City | MASON OH 450402303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 450402303 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIANCE MEDICAL PRODUCTS FX920 LOW VOLTAGE CONTROL CHAIR |
| Generic Name | CHAIR, OPHTHALMIC, AC-POWERED |
| Product Code | HME |
| Date Received | 2017-09-25 |
| Model Number | FX920 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | SEE SERIAL NUMBER |
| Device Expiration Date | 2017-09-13 |
| Operator | MEDICAL ASSISTANT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 3535 KINGS MILLS ROAD MASON OH 450402303 US 450402303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |