FDA.reportPublic FDA data

MAUDE MDR 7969536

MDR report key
7969536
Report number
2918630-2018-00002
Event key
0
Event type
3
Date of event
2018-09-26
Date received
2018-10-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. WILLIAM GUSTAFSON
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLEX ELITE 9000 SS-OCTTOMOGRAPHY, OPTICAL COHERENCECARL ZEISS MEDITEC, INC.OBO9000266002-1163-096N/AN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-160

Event Narratives#

D

Patient 1

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A USER HAD RECEIVED AN ELECTRIC SHOCK WHILE OPERATING THE PLEX ELITE 9000 POWER TABLE. THE USER WAS EXAMINED BY LOCAL MEDICAL PROFESSIONALS AND IT WAS REPORTED THAT THE USER HAD NOT BEEN INJURED. A PHOTO HAS BEEN PROVIDED TO THE MANUFACTURER SHOWING DAMAGED INSULATION ON A WIRE IN THE ENCLOSURE OF THE POWER TABLE'S UP/DOWN SWITCH.