MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-11 for MIDMARK 630-004 manufactured by Midmark Corp..
[2896103]
The facility staff claims the table continued to run after the control was released. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[10174726]
The product has not been returned at this time. An investigation was done on site by a local tech that did not result in any conclusion. The problem could not be duplicated. An investigation will be conducted when the product is returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2012-00026 |
| MDR Report Key | 2752603 |
| Report Source | 06 |
| Date Received | 2012-09-11 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-08-12 |
| Date Mfgr Received | 2012-08-12 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2012-12-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG RAMMEL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2012-09-11 |
| Model Number | 630-004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-11 |