FDA.reportPublic FDA data

MAUDE MDR 3767037

MDR report key
3767037
Report number
9610966-2014-00001
Event key
0
Event type
3
Date of event
2013-09-08
Date received
2014-01-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BERT VORSTENBOSCH, MGR
Address
PHILIPSWEG 1 MAASTRICHT 6227 NL
Phone
338-338-3382
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESAOTEULTRASONIC DIAGNOSTIC TRANSDUCERESAOTE EUROPE B.V.FTYPA230E96000165000N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-020

Event Narratives#

D

Patient 1

ON (B)(6) 2013, ESAOTE EUROPE BV WAS NOTIFIED BY ESAOTE (B)(4) THAT THEY RECEIVED A COMPLAINT FROM A REMANUFACTURER OF AN ESAOTE CARDIAC PROBE, PA230E. THE PROBE HEATED EXCESSIVELY DURING A SCAN OF A DIFFICULT TO IMAGE PT. THERE WAS NO REPORTED INJURY TO THE PT OR USER.

N

Patient 1

AS ESAOTE, (B)(4) IS THE ORIGINAL MANUFACTURER, THE UNIT INVOLVED IN THE REPORT HAS BEEN EVALUATED BY ESAOTE, (B)(4). EVALUATION RESULTS FROM ESAOTE INDICATE THE DEVICE ARE AT THE UPPER LIMIT OF SPECIFICATIONS. IF THE UNITS AT THE UPPER LIMIT OF SPECIFICATIONS INCREASE THE POWER TO THE ALLOWED MAXIMUM, IN COMBINATION WITH SPECIFIC SETTINGS TO SCAN DIFFICULT TO IMAGE PTS, PROBES AT THE UPPER LIMIT OF SPECIFICATIONS MAY EXCEED TEMPERATURE LIMITS AT THE SURFACE. THIS RESULTS IN THE POSSIBILITY OF A PT EXPERIENCING SOME DISCOMFORT. ESAOTE EUROPE BV AS PART OF THE ESAOTE GROUP HAS SOLD THE PA230 TOGETHER WITH SEVERAL SCANNERS IN THE USA. THERE ARE MORE THAN (B)(4) TRANSDUCERS IN THE FIELD OVER A PERIOD OF 10 YEARS AND ESAOTE (B)(4) AND ESAOTE EUROPE BV HAVE NOT RECEIVED ANY SIMILAR COMPLAINT. IN ORDER TO INCREASE THE SAFETY MARGIN TO ENSURE THAT THE TEMPERATURE LIMIT WILL NOT BE EXCEEDED BY TRANSDUCERS AT THE UPPER LIMIT OF SPECIFICATIONS, ESAOTE EUROPE BV WILL BE ISSUING A NON-MANDATORY SOFTWARE UPGRADE WITHIN Q1 2014.