MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2009-09-01 for VASSCAN TABLE MODEL 2184 2084 manufactured by Medical Positioning, Inc..
[1230472]
On (b)(6) 2009, medical positioning, inc. Received a copy of a lawsuit filed in (b)(6) against (b)(4) and medical positioning, inc. , alleging that an incident, which took place on (b)(6) 2007, caused serious injury to the plaintiff. The lawsuit alleges that "the plaintiff, after medical tests had been completed on (b)(6) 2007, sat up in the examination bed and turned his legs to the side of the bed, as if to get off. While sitting on the side of the bed, it suddenly collapsed throwing the plaintiff violently onto the floor". The lawsuit goes on to state that "the plaintiff's shoulder was serious injured, and since the plaintiff uses a cane to walk, he has been reduced to using a motorized wheelchair. " medical positioning, inc. Received a phone call from the (b)(6) medical center at (b)(6) on (b)(6) 2007, stating that as a pt was getting off the table after a medical procedure, that a weld, which connects an electric actuator to the frame broke free, causing the head of the table to suddenly drop. As is medical positioning, inc. 's standard practice, an investigation was launched. The personnel at the (b)(6) medical center in (b)(6) reporting the incident, stated by their interview of the pt and their professional observation that the pt had sustained no injury. Because their examination found no injury to the pt and the pt did not complain of injury, medical positioning, inc. Assessed that no injury was sustained by the pt. As a result of this incident, medical positioning, inc. Repaired the medical table by replacing all affected frame components.
Patient Sequence No: 1, Text Type: D, B5
[8412811]
This particular table ((b)(6)) was manufactured in 2004. After investigation of the reported event and examination of the returned metal structure, it was confirmed that separation occurred between the lower trendelenburg actuator mounting tab and the column top plate. This was the first occurrence of this type, so medical positioning, inc. Examined all existing, in house inventory and began monitoring any reports involving similar tables manufactured during this time period. Medical positioning, inc. Has continued to monitor this event and has found no similar occurrences in similar tables manufactured before, during or after this time period. Medical positioning, inc. Was never made aware of the weight of the pt, or if the weight of the pt exceeded the 350lb weight capacity of the table at the time it was manufactured.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2009-00001 |
| MDR Report Key | 1474617 |
| Report Source | 00,05,06 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-09-01 |
| Date of Event | 2007-07-26 |
| Date Mfgr Received | 2009-08-10 |
| Device Manufacturer Date | 2004-01-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RUBEN SALINAS |
| 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 | VASSCAN TABLE MODEL 2184 |
| Generic Name | GENERAL VASCULAR ULTRASOUND TABLE |
| Product Code | LGX |
| Date Received | 2009-09-01 |
| Model Number | 2084 |
| ID Number | 797612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2009-09-01 |