MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-28 for MULTISCAN TABLE MODEL 8083 manufactured by Medical Positioning, Inc..
[1898395]
With the pt on the table in the fowler position (sitting up with back being supported by the upper portion of the table), the lower fowler actuator mount tab broke away from the table causing the head of the table to fall to the floor. The pt was able to avoid injury by utilizing the safety mechanisms built into the table. Specifically, the pt grabbed onto the safety rail before he fell.
Patient Sequence No: 1, Text Type: D, B5
[8932174]
Incident resulted from weld failure. While less than 0. 02% welds have failed, the incidence of failure in 2004 is higher than in other years. For that reason, all customers with models who have reported weld failure, and are from batches of steel used in 2004, have been contacted and an upgrade was installed to ensure no failures in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2011-00001 |
| MDR Report Key | 1977266 |
| Report Source | 05,06 |
| Date Received | 2011-01-28 |
| Date of Report | 2011-01-25 |
| Date of Event | 2009-11-09 |
| Device Manufacturer Date | 2004-07-19 |
| Date Added to Maude | 2011-03-25 |
| 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 | LAURA BRADY |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8164741555 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISCAN TABLE MODEL 8083 |
| Generic Name | GENERAL ULTRASOUND TABLE |
| Product Code | LGX |
| Date Received | 2011-01-28 |
| Model Number | 8083 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-28 |