FDA.reportPublic FDA data

MAUDE MDR 3135332

MDR report key
3135332
Report number
MW5030299
Event key
0
Event type
3
Date of event
2013-05-08
Date received
2013-05-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPS X-RAYNONEIZO N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-210

Event Narratives#

D

Patient 1

THE MAIN (B)(4) X-RAY DISPLAY IN LAB 3 HAD A MAJOR FAILURE WITH THE MOUNTING SYSTEM. WHEN I ARRIVED IN LAB 3, THE DISPLAY WAS LYING ON THE FLOOR. THE DRIVE MECHANISM FOR THE DISPLAY TO GO UP AND DOWN CONSISTS OF 2 SQUARE PIPES WITH A BOLT INSIDE THE PIPES AND A MOTOR THAT DRIVES A GEAR UP AND DOWN THE BOLT. THE BOLT LOOKED LIKE IT DID NOT HAVE ANY DAMAGE TO IT. THE TREADS ON THE BOLT LOOKED FINE. IT SEEMED LIKE THE FAILURE WAS WITH THE DRIVE GEAR PORTION OF THE MECHANISM. UNFORTUNATELY THE MOTOR AND DRIVE GEAR PART ARE INSIDE THE SECOND PIPE WHERE YOU COULD NOT SEE IT VERY WELL. SO WE COULD NOT DETERMINE FOR SURE WHAT FAILED W/O TAKING THE DRIVE MECHANISM OUT OF THE SQUARE TUBE. DMS REMOVED THE DISPLAY AND MOUNTING PARTS SO WE WILL HAVE TO FIND OUT FROM THEM WHAT THEY FOUND WHEN IT WAS TAKEN APART. ALSO THERE DID NOT SEEM TO BE A FAIL SAFE IN PLACE THAT WOULD PREVENT THE DISPLAY FROM FALLING ALL THE WAY TO THE FLOOR IF THE DRIVE MECHANISM FAILED LIKE OURS DID.