MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-29 for 104181 EASYDIAGNOST 9" II DSI-U manufactured by Philips Medical Systems North America.
[15625381]
Diagnostic radiology unit has a button that, when pushed, allows the table to be tilted by turning a lever. The button is such that it can easily be pushed without the users knowledge. Also, when pushed, the button remains activated until it is pushed again to unactivate. There is no "time-out" or reminder to the user that the button is activated. In this case, the button was activated from a previous patient, and was not turned off by the radiology technologist. As the tech was moving the x-ray tube around the flouro tower, the power cables to the tube caught the table tilt lever, tilted the table down and the patient slid off the table to the floor. Note: philips checked the equipment and found it is working as designed. Our biomed department developed a raised area around the button and a plexiglass cover over the tilt lever to prevent their accidentally being activated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009788 |
| MDR Report Key | 1301933 |
| Date Received | 2009-01-29 |
| Date of Report | 2009-01-29 |
| Date of Event | 2009-01-15 |
| Date Added to Maude | 2009-02-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 104181 EASYDIAGNOST 9" II DSI-U |
| Generic Name | X-RAY TUBE AND FLOURO TOWER |
| Product Code | ITY |
| Date Received | 2009-01-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS NORTH AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-29 |