FDA.reportPublic FDA data

MAUDE MDR 5067272

MDR report key
5067272
Report number
3002807968-2015-00021
Event key
0
Event type
3
Date of event
2015-08-05
Date received
2015-09-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
AUSTRASSE 25 BASEL CH 40 SZ
Phone
827-827-8273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOSCA 500 USATOSCA 500 USA MONITORDPZ5201008Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-080

Event Narratives#

N

Patient 1

THE MONITOR TEMPERATURE WAS NOTED AT 44 DEGREES CELSIUS. THE USER MANUAL FOR THE TOSCA 500 STATES A RECOMMENDED TEMPERATURE OF 42 DEGREES CELSIUS AND A MAXIMUM TEMPERATURE OF 44 DEGREES CELSIUS. THE CUSTOMER EXPLAINED THAT THIS MONITOR WAS USED FOR SLEEP STUDIES THAT CAN LAST UP TO 10 HOURS, AND THAT THE SITE TIME WAS SET AT 9 HOURS. HOWEVER, THE USER MANUAL FOR TOSCA 500 INSTRUCTS A MAXIMUM SITE TIME OF 4 HOURS WHEN SETTING THE TEMPERATURE AT 44 DEGREES CELSIUS. THE PROLONGED SITE TIME AT THE HIGH TEMPERATURE INDICATES THAT THE EVENT WAS CAUSED BY A USER ERROR.

D

Patient 1

(B)(4).

N

Patient 1

IN THE INITIAL REPORT ADVERSE EVENT WAS CHECKED BUT IT WAS NOT AN ADVERSE EVENT BUT A MALFUNCTION DUE TO A USE ERROR WHY NO MDR SHOULD HAVE BEEN FILED. SERIOUS INJURY SHOULD HAVE BEEN LEFT BLANK IN INITIAL REPORT. INITIAL REPORT: THE COVER LETTER STATES "...FOR A SERIOUS INJURY INVOLVING CLINITUBES". THE CASE CONCERNS TCM TOSCA 500 SENSOR 92, SO THE CORRECT STATEMENT IS "...FOR A SERIOUS INJURY INVOLVING TCM TOSCA 500 SENSOR 92".