MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-03 for ULTRASCAN TABLE 8089 * manufactured by Medical Positioning, Inc..
[17531024]
Due to the design, when patients are getting down from the gurney, they are sometimes getting their pant legs caught up on the metal piece that sticks up from the casters, causing them to fall. It is realized that this is an older model, and that the newer models have a different design, but it is felt that there should be some sort of manufacturer "fix" to these products that are still in use. We would recommend a recall of the older models. ====================== health professional's impression======================poor design. A 2-3 inch metal bar sticks up from the bottom caster wheels. When patients exit the gurney (even though they are supposed to exit from the middle of the gurney) they get caught on this part of the gurney. ====================== manufacturer response for ultrascan table, ultrascan table======================they had reserched it in the past but were unable to reproduce it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1958805 |
| MDR Report Key | 1958805 |
| Date Received | 2011-01-03 |
| Date of Report | 2011-01-03 |
| Date of Event | 2010-12-14 |
| Report Date | 2011-01-03 |
| Date Reported to FDA | 2011-01-03 |
| Date Added to Maude | 2011-01-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASCAN TABLE |
| Generic Name | ULTRASCAN TABLE |
| Product Code | LGX |
| Date Received | 2011-01-03 |
| Model Number | 8089 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | 1717 WASHINGTON ST. KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-03 |