MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-02 for HAUSTED VIC VIDEOFLUOROSCOPIC IMAGING CHAIR * manufactured by Hausted Patient Handling Systems, Llc.
[2382947]
While scanning patient's esophagus using a videofluoroscopic swallow chair, the fluoroscopy arm was moved too low and an alarm sounded. Movement functions of the fluoro arm then stopped and did not allow the arm to be raised, trapping the patient's legs. Upon investigation, there is a button on the main console and on remote control that will restore lifting capability to the fluoroscopy arm, but the staff did not recall that during the event. There are "hall effect" switches in the cowling that were replaced in 2008 and known to be functional at the time of the occurrence. These sense an obstruction and stop further movement. These were operational, as was the mechanism to restore the lifting function. It appears patient's low bmi may have contributed to events since chair is limited in height, and patient was low in the chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2240746 |
| MDR Report Key | 2240746 |
| Date Received | 2011-09-02 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-07-01 |
| Report Date | 2011-09-02 |
| Date Reported to FDA | 2011-09-02 |
| Date Added to Maude | 2011-09-09 |
| 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 | HAUSTED VIC VIDEOFLUOROSCOPIC IMAGING CHAIR |
| Generic Name | CHAIR, IMAGING, VIDEOFLUOROSCOPIC |
| Product Code | FZK |
| Date Received | 2011-09-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAUSTED PATIENT HANDLING SYSTEMS, LLC |
| Manufacturer Address | 2511 MIDPARK ROAD MONTGOMERY AL 36109 US 36109 |
| Brand Name | MULTIDIAGNOST 4 |
| Generic Name | X-RAY SYSTEM, RAD/FLUORO |
| Product Code | JAA |
| Date Received | 2011-09-02 |
| Model Number | MULTIDIAGNOST 4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Age | 3 YR |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS MEDICAL SYSTEMS NORTH AMERICA, INC |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-02 |