MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-06-27 for MIDMARK 625-001 manufactured by Midmark Corp..
[20956572]
The customer stated the table lowered 2 inches with a pt on the table.
Patient Sequence No: 1, Text Type: D, B5
[21223289]
An independent service company inspected the table. They could find no problems that would have caused the table to suddenly lower the 2 inches reported by the operator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00020 |
| MDR Report Key | 2187417 |
| Report Source | 00,06 |
| Date Received | 2011-06-27 |
| Date of Report | 2011-06-23 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-01 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-05-10 |
| 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 | DONALD CARR |
| 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 | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-06-27 |
| 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 CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-27 |