MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-01 for MIDMARK 630-020 manufactured by Midmark Corp..
[24247076]
Midmark received the unit and continues investigation. No root cause has yet been determined. Midmark will provide further update upon conclusion of investigation or verification of root cause.
Patient Sequence No: 1, Text Type: N, H10
[24247077]
Patient was in the seated position. The medical assistant lowered the back and heard a noise. The top end of the table dropped toward the floor. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2015-00005 |
| MDR Report Key | 4990313 |
| Date Received | 2015-08-01 |
| Date of Report | 2015-07-31 |
| Date of Event | 2015-07-08 |
| Date Mfgr Received | 2015-07-08 |
| Device Manufacturer Date | 2015-03-03 |
| Date Added to Maude | 2015-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | JANE CARROL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MIDMARK |
| Generic Name | PROCEDURE TABLE |
| Product Code | LGX |
| Date Received | 2015-08-01 |
| Returned To Mfg | 2015-07-22 |
| Model Number | 630-020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-01 |