MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-02-03 for MIDMARK 625-001 manufactured by Midmark Corporation.
[18922296]
A pt was on the table when the table fell several inches. No injuries were reported. Table did not have power after this occurred.
Patient Sequence No: 1, Text Type: D, B5
[19096177]
Examination of similar events indicates an obstruction was under the table and the table was lowered onto it. When the table was lowered, the obstruction was pinched between the base of the table and the floor. When this occurs the control board fuse can fail which can cause a loss of power. This was what was described during the incident. This process is described in the products user's guide. Failure to correctly look for obstructions under the table can result in the type of damage seen with this table. Service personnel replaced the control board and reviewed the product for functionality. Confirmed all functions performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2014-00001 |
| MDR Report Key | 3809903 |
| Report Source | 06,07 |
| Date Received | 2014-02-03 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-02 |
| Date Mfgr Received | 2014-01-02 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-05-30 |
| 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 DRIVE |
| 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 | CHAIR, SURGICAL, AC-POWERED |
| Product Code | LGX |
| Date Received | 2014-02-03 |
| Model Number | 625-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-03 |