FDA.reportPublic FDA data

MAUDE MDR 2240746

MDR report key
2240746
Report number
2240746
Event key
0
Event type
3
Date of event
2011-07-01
Date received
2011-09-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HAUSTED VIC VIDEOFLUOROSCOPIC IMAGING CHAIRCHAIR, IMAGING, VIDEOFLUOROSCOPICHAUSTED PATIENT HANDLING SYSTEMS, LLCFZK*** Y
2MULTIDIAGNOST 4X-RAY SYSTEM, RAD/FLUOROPHILLIPS MEDICAL SYSTEMS NORTH AMERICA, INCJAAMULTIDIAGNOST 4**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-020

Event Narratives#

D

Patient 1

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.