FDA.reportPublic FDA data

MAUDE MDR 9731889

MDR report key
9731889
Report number
3010825766-2020-00002
Event key
0
Event type
3
Date of event
2020-01-24
Date received
2020-02-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS EVA BALZAROTTI
Address
VIA TORRACCIA 26 NOVAZZANO 6883 SZ
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLEXLABLABORATORY AUTOMATION SYSTEMINPECO SACEMFLXN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-200

Event Narratives#

N

Patient 1

THE PROCEDURE FOLLOWED TO INSTALL THE HARDWARE KIT INDICATES FIRST OF ALL TO "CUT OFF ENERGY SUPPLIES". THE FSE ASKED BY EMAIL THAT THE LABORATORY ELECTRICAL POWER SUPPLY WAS OFF, BUT THE MAIN ELECTRICAL PANEL WAS STILL CONNECTED TO POWER. THE FSE DID NOT CHECKED THAT THE CIRCUIT WAS DEAD BEFORE STARTING THE REPLACEMENT AND DID NOT CUT OFF THE AUTOMATION SYSTEM POWER SUPPLY AS RECOMMENDED IN THE PROCEDURE. THE EVENT WAS CAUSED BY THE FSE ERROR. THE HARDWARE KIT AND THE INSTALLATION PROCEDURE WERE REVIEWED AND THERE IS NO NEED OF CHANGES. THE AUTOMATION SYSTEM IS PERFORMING AS EXPECTED. NO FURTHER ACTIONS ARE REQUIRED.

D

Patient 1

AN INPECO FSE RECEIVED AN ELECTRICAL SHOCK WHILE HE WAS WORKING ON THE AUTOMATION SYSTEM, SPECIFICALLY HIS RIGHT HAND TOUCHED A LIVE 240V WIRE WHILE HE WAS REPLACING THE CIRCUIT BREAKER OF A DISTRIBUTION BOARD OF THE HIGH VOLUME STORAGE.