FDA.reportPublic FDA data

MAUDE MDR 5453121

MDR report key
5453121
Report number
2247117-2016-00008
Event key
0
Event type
3
Date of event
2016-01-26
Date received
2016-02-23
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
12016-02-230

Event Narratives#

N

Patient 1

THE CSE WAS AT THE CUSTOMER SITE TO RESOLVE "CAROUSEL TEMPERATURE" ERRORS WHICH SHUT THE SYSTEM DOWN. THE CSE CHECKED THE SYSTEM AND FOUND VOLTAGE FLUCTUATIONS. THE CSE INSTALLED A NEW POWER SUPPLY, VERIFIED ALL VOLTAGES, PRIMED THE SYSTEM AND RAN A WATER TEST. THE CSE ALSO REPLACED THE DILUTER ASSEMBLY. THE CUSTOMER RAN QUALITY CONTROLS, WHICH RESULTED WITHIN ACCEPTABLE RANGE. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

D

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPORTED THAT SMOKE WAS EMITTED FROM AN IMMULITE INSTRUMENT AFTER PERFORMING TROUBLESHOOTING ON THE SYSTEM AND INSTALLING NEW PARTS. THE CSE CHECKED THE SYSTEM AND FOUND THAT WIRES WERE OVERHEATED. THERE ARE NO REPORTS OF INJURIES, FIRE, BURNS OR INHALATION. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.

N

Patient 1

THE INITIAL MDR 2247117-2016-00008 WAS FILED ON FEBRUARY 23, 2016. ADDITIONAL INFORMATION (01/26/2016): THE OVERHEATED WIRES WERE FOUND IN THE HARNESS FROM THE MOTHER PRINTED CIRCUIT BOARD TO THE DILUTER ASSEMBLY. THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE HARNESS TO DILUTER AND THE MOTHER PRINTED CIRCUIT BOARD. SIEMENS IS INVESTIGATING THE ISSUE.

N

Patient 1

THE INITIAL MDR 2247117-2016-00008 WAS FILED ON FEBRUARY 23, 2016. SUPPLEMENTAL MDR 2247117-2016-00008_S1 WAS FILED ON FEBRUARY 23, 2016. ADDITIONAL INFORMATION (01/26/2016): THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS OVERHEATING OF WIRE INSULATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.