FDA.reportPublic FDA data

MAUDE MDR 5248743

MDR report key
5248743
Report number
2247117-2015-00063
Event key
0
Event type
3
Date of event
2015-10-30
Date received
2015-11-24
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
MARGARITA KARAN
Address
511 BENEDICT AVE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMMULITEIMMULITESIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITEN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-240

Event Narratives#

N

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE REPLACED THE COMPUTER. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS RELATED TO MALFUNCTION OF THE COMPUTER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

THE OPERATOR ON AN IMMULITE INSTRUMENT REPORTED THAT WHEN THE POWER CORD WAS PLUGGED, THE COMPUTER'S INTERNAL POWER SUPPLY SPARKED AND SMOKED. THE OPERATOR UNPLUGGED THE DEVICE IMMEDIATELY. THERE ARE NO REPORTS OF INJURIES, BURNS OR INHALATION. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.