TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-07-21 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.

Event Text Entries

[16178734] 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. Ten patients were affected. Currently, the patient information received for all patients is identical. More information has been requested. This report regards patient number 7. Mdr reports for the affected patients will be submitted with mdr reference 302807968-2014-00023 to 3002807968-2014-00032.
Patient Sequence No: 1, Text Type: D, B5


[16317169] The electrode has been requested 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 tis 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 2nd degree burn marks. 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807968-2014-00029
MDR Report Key3976214
Report Source01,05,07
Date Received2014-07-21
Date of Report2014-06-26
Date of Event2014-01-01
Date Mfgr Received2014-05-02
Device Manufacturer Date2010-12-01
Date Added to Maude2014-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer StreetAKANDEVEJ 21
Manufacturer CityBRONSHOJ
Manufacturer CountryDA
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSCUTANEOUS BLOOD GAS MONITOR
Generic NameTCM4 MONITORING SYSTEM
Product CodeLKD
Date Received2014-07-21
Model NumberTCM4 SERIES
Catalog Number391-880
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAKANDEVEJ 21 BRONSHOJ DA


Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-21

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