MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2012-08-21 for ULTRASCAN TABLE 8094 manufactured by Medical Positioning, Inc..
[18060463]
The pt was instructed to change into a gown and to get on the table and a staff member would come back to do the procedure. The pt was then left alone. While this pt was unattended she fell. She had skin break on her elbow and complained of hip pain. She was immediately taken to the emergency dept. X-rays were negative for any broken bones and only a shoulder sprain was described in the emergency dept discharge summary. The pt was then released to go home on that same day. A staff member interviewed the pt while she was in the emergency room dept on (b)(6) 2012, and she explained that she had scooted backwards and tried to lift her buttocks up to get onto the tablet at the foot section. She reports that the foot section gave way and she fell. The foot section is designed to fold up and down. The product was not broken or damaged in any way to cause the event. The hosp staff attempted to recreate the event several different ways and were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[18418861]
At this time no remedial action will be taken. The end user did not heed two different safety warnings that appear in the manual and on the product itself. First, there is a product warning which states not to leave the pt unattended while in use (this is an imaging surface not a pt bed). Second, there is a safety warning to not place full body weight on the foot end of the product as it could lead to tipping of the device. Medical positioning, inc shall utilize its customer complaint procedure to continue monitoring for add'l events which could constitute a trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2012-00005 |
| MDR Report Key | 2718726 |
| Report Source | 04,05,06 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-08-21 |
| Date of Event | 2012-08-10 |
| Device Manufacturer Date | 2006-03-29 |
| Date Added to Maude | 2012-09-04 |
| 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 | JOE HURTIG, QLTY MGR.,MGMT RE |
| Manufacturer Street | 1717 WASHINGTON ST. |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASCAN TABLE |
| Generic Name | ULTRASCAN TABLE |
| Product Code | LGX |
| Date Received | 2012-08-21 |
| Model Number | 8094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | KANSAS CITY MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-21 |