MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2011-09-07 for MIDMARK 411-016 manufactured by Midmark Corp..
[2256771]
Customer stated the table dropped causing the pt to fall off. (no injury).
Patient Sequence No: 1, Text Type: D, B5
[9413846]
A service co was sent to evaluate the table. They could not find any issues. The table ran normally and the dropping issue could not be duplicated. The facility was advised that the table is past its design life.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00027 |
| MDR Report Key | 2272831 |
| Report Source | 06,07,08 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-09-07 |
| Date of Event | 2011-08-16 |
| Date Mfgr Received | 2011-08-16 |
| Device Manufacturer Date | 1998-04-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2011-09-07 |
| Model Number | 411-016 |
| 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 | 2011-09-07 |