MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-10 for MIDMARK 630-004 manufactured by Midmark Corp..
[4660959]
(b)(6), md's office reported that a pt received a shock during a procedure from a cauterization equipment when they touched the midmark 630 examination table.
Patient Sequence No: 1, Text Type: D, B5
[12112113]
The product has not been returned at this time. A site eval was performed by a tech. The site indicated that the cauterization equipment caused a shock when a pt came in contact with a different product, described as a cart. The cauterization machine was plugged into a wall outlet, not the outlet provided for medical equipment on the midmark 630. A recommendation was given to the site to eval the cauterization equipment for proper construction. The site did not give model info on the cauterization equipment at the time of this report. Based on the site eval, midmark is able to confirm that the midmark 630 examination table was not the cause of the pt shock.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2014-00007 |
| MDR Report Key | 3856308 |
| Report Source | 06,07 |
| Date Received | 2014-04-10 |
| Date of Report | 2014-04-10 |
| Date of Event | 2014-03-11 |
| Date Mfgr Received | 2014-03-11 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-06-20 |
| 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 | 0 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2014-04-10 |
| Model Number | 630-004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-10 |