MAUDE MDR 7633941

MDR report key
7633941
Report number
9617251-2018-00001
Event key
0
Event type
3
Date of event
2018-05-24
Date received
2018-06-25
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#

Contact
MS. MARIA GOMEZ
Address
PELAYA, 9 . POL. IND. RIO DE JANEIRO ALGETE, MADRID 28110 SP
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SEDECALDIAGNOSTIC X-RAY OVERHEAD TUBE STANDSEDECAL SAIYBNOVA FAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-250

Event Narratives#

N

Patient 1

THE TWO CABLES AND PULLEY WERE TAKEN TO SEDECAL THE SAME MORNING OF MAY 25TH FOR A DEEPER ANALYSIS. THE REST OF THE DAMAGED EQUIPMENT, ONCE REMOVED, WAS TAKEN TO SEDECAL FACILITIES FOR FURTHER INVESTIGATION. ON MONDAY MAY 28TH, WE PROCEEDED TO ASSEMBLE THE PULLEY REMOVED IN A SIMILAR EQUIPMENT EXISTING AT SEDECAL FACILITIES. WHEN OPERATING THE EQUIPMENT IN SUCH CONDITIONS, AN UNUSUAL NOISE WAS DETECTED IN THE VERTICAL MOVEMENT. ONCE THE CAUSE OF THIS WAS ANALYZED, IT WAS FOUND THAT THE NOISE WAS DUE TO FRICTION BETWEEN THE TWO STEEL CABLES, WHICH HAD COME INTO CONTACT DUE TO THE GREATER WEAR PRODUCED IN ONE OF THE GROOVES OF THE PULLEY IN QUESTION WE WILL COMMUNICATE TO ALL CUSTOMERS A MANDATORY REVIEW OF THE ENTIRE INSTALLED BASE BY THE VARIOUS TECHNICAL SERVICES TO VERIFY THE STATUS OF THIS PULLEY AND THE TWO STEEL CABLES, PROCEEDING TO CHANGE THEM IN CASE OF DETECTING ANY DETERIORATION IN THE CABLES OR IRREGULAR OR EXCESSIVE WEAR OF THE PULLEY.

D

Patient 1

THIS INCIDENT INVOLVES A MALFUNCTION IN A DIAGNOSTIC X-RAY SYSTEM, SPECIFICALLY THE OVERHEAD TUBE CRANE. THIS IS A CEILING MOUNTED DEVICE WHICH HOLDS THE X-RAY TUBE AND THE COLLIMATOR. THIS ASSEMBLY CAN BE MOVED BOTH HORIZONTALLY AND VERTICALLY. IN THIS CASE, THE ASSEMBLY FELL TO THE GROUND WITHOUT ANY COMMAND FROM THE OPERATOR TO DO THIS. HAD THERE BEEN A PERSON UNDERNEATH THE TUBE CRANE AT THE TIME, THAT PERSON COULD HAVE BEEN SEVERELY INJURED OR KILLED BECAUSE OF THE MASS INVOLVED.