MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-31 for ULTRASCAN TABLE 8089 manufactured by Medical Positioning, Inc..
[1921109]
On (b)(6) 2011, medical positioning, inc became aware of an incident at (b)(6) hosp where a pt tripped and fell when exiting a medical imaging platform mfg by the company when a copy of medwatch form fda 3500a with uf/importer reporter # (b)(4) was received. According to the report "... When pts 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.... "
Patient Sequence No: 1, Text Type: D, B5
[9223157]
The company has released (b)(4) ultrascan tables with an identical base frame design as one which is the subject of this report. The company has received only two complaints pertaining to pts tripping when exiting the table. Both of the complaints have come from the same customer, (b)(6). Additionally, as a result of the first complaint, the company performed testing in an attempt to recreate the result reported by the customer. The tested was completed in the presence of several people including fda (b)(6), during a routine level ii qsit investigation which took place between (b)(6) 2007 and (b)(6) 2007 (investigation remarks attached to this report). The testing and results were initially reported on medwatch form fda 3500a mfr report# 1932056-2007-00003. During the testing, the condition of a fall could not be recreated. Due to the lack of complaints (from more than one customer) and the results of testing performed as a result of initial customer complaint, the company stands by its design and will not issue any product correction or recall notice to customer owning tables with identical design. The company will however, to monitor for customer complaints and action will be taken as necessary if the issue becomes repetitive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2011-00002 |
| MDR Report Key | 2018775 |
| Report Source | 05,06 |
| Date Received | 2011-01-31 |
| Date of Report | 2011-01-28 |
| Date of Event | 2010-12-14 |
| Device Manufacturer Date | 2006-09-08 |
| 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 | 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASCAN TABLE |
| Generic Name | GENERAL ULTRASOUND TABLE |
| Product Code | LGX |
| Date Received | 2011-01-31 |
| Model Number | 8089 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-01-31 |