MAUDE MDR 2485616

MDR report key
2485616
Report number
2485616
Event key
0
Event type
3
Date of event
2012-02-27
Date received
2012-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1CLEAR-PB MOBILE BARRIERSSHIELD, X-RAY, MOBILEFLUKE BIOMEDICAL (FORMERLY NUCLEAR ASSOCIATES)IWS56-604**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-060

Event Narratives#

D

Patient 1

THE PATIENT WAS UNDERGOING CORONARY ANGIOGRAPHY. THE ATTENDING PHYSICIAN WAS WALKING ACROSS THE PROCEDURE ROOM IN ORDER TO INSERT SOME DOCUMENTS INTO THE PATIENT'S CHART. SINCE FLUOROSCOPY WAS ONGOING, HE WAS MOVING THE MOBILE X-RAY SHIELD ACROSS THE ROOM SO THAT HE WOULD REMAIN BEHIND IT. JUST AFTER HE LET GO, THE UPPER PORTION OF THE WINDOW SNAPPED OFF JUST ABOVE THE VERTICAL MOUNTS ON BOTH SIDES. THE CRACKED EDGE WAS SMOOTH BUT NOT SHARP LIKE GLASS. THE PIECE THAT FELL TO THE FLOOR DID NOT SHATTER NOR STRIKE ANYONE OR ANYTHING THAT WOULD HAVE COMPROMISED THE PROCEDURE.STAFF FORTUNATELY SAVED THE TWO PARTS OF THE BROKEN WINDOW. IT'S MADE OF PLASTIC, NOT GLASS SO THE PART THAT FELL DIDN'T SHATTER. THE DEVICE IS CONSIDERED A RADIATION SAFETY DEVICE BY THE MANUFACTURER. MY OPINION IS THAT THERE WAS A NOTCH NEAR ONE OF THE SIDE SUPPORT CHANNELS AND THAT THE CONTINUED FLEXING AND HANDLING OF THE UNSUPPORTED UPPER PORTION OF THE WINDOW OVER A LONG PERIOD OF TIME RESULTED IN A CRACK GROWING FROM THE NOTCH UNTIL THIS CATASTROPHIC EVENT OCCURRED.