FDA.reportPublic FDA data

MAUDE MDR 3976229

MDR report key
3976229
Report number
3002807968-2014-00028
Event key
0
Event type
3
Date received
2014-07-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
AKANDEVEJ 21 BRONSHOJ DK-27 DA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSCUTANEOUS BLOOD GAS MONITORTCM4 MONITORING SYSTEMRADIOMETER MEDICAL APSLKDTCM4 SERIES391-880Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-2101. O

Event Narratives#

D

Patient 1

ACCORDING TO THE COMPLAINT SKIN BLISTERS WERE RECEIVED AFTER USING THE TCM4 SENSOR FOR 9 HOURS AT THE SAME LOCATION WITH THE TEMPERATURE SET AT 45 DEGREES. 10 PATIENTS WERE AFFECTED. CURRENTLY, THE PATIENT INFORMATION RECEIVED FOR ALL PATIENTS IS IDENTICAL. MORE INFORMATION HAS BEEN REQUESTED. THIS REPORT REGARDS PATIENT NR 6. MDR REPORTS FOR THE AFFECTED PATIENTS WILL BE SUBMITTED WITH MDR REFERENCE 3002807968-2014-00023 TO 3002807968-2014-00032.

N

Patient 1

THE ELECTRODE HAS BEEN REQUESTED SENT BACK FOR INVESTIGATION TO DETERMINE IF THIS PROBLEM HAS BEEN CAUSED BY A PRODUCT MALFUNCTION OR A USER ERROR. BASED ON THE EVENT DESCRIPTION THIS CASE COULD BE CAUSED BY A USER ERROR SINCE THE ELECTRODE TEMPERATURE WAS SET HIGHER THAN RECOMMENDED AND FOR 9 HOURS INSTEAD OF ONLY 4 HOURS. IT WILL BE DETERMINED IF THIS EVENT WAS CAUSED BY A PRODUCT MALFUNCTION OR A USER ERROR WHEN THE ELECTRODE HAS BEEN INVESTIGATED. BASED ON THE PICTURES RECEIVED, THE BLISTERS ARE EVALUATED TO BE SECOND DEGREE BURN MARKS. NO INFORMATION OF TREATMENT APPLIED HAS BEEN RECEIVED. THIS INJURY IS EVALUATED AS REPORTABLE, BUT THE INJURY IS ONLY EVALUATED AS MINOR AS IT DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY, AS DESCRIBED IN THE INSTRUCTIONS FOR THIS FORM.