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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER AMERICA; SENSOR CASSETTE
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RADIOMETER AMERICA; SENSOR CASSETTE Back to Search Results
Model Number 945-714
Device Problems Failure to Cycle (1142); Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 07/21/2014
Event Type  Injury  
Event Description
A new sensor cassette was placed on the radiometer abl 80-coox blood gas instrument (b)(6) 2014 at approximately 1500 because all the test had been used.Part #945-714 lot #205624, instrument serial #(b)(4).Once changed and installed, the instrument performs a system cycle (internal quality control check) anda 2pt calibration.The system cycle did not perform the system cycle but performed the 2pt calibration.System cycles are suppose to perform every 8 hours daily.The 2pt calibration performs after a sensor cassette has been changed then and 30 minutes afterwards.In this case, the system cycle failed to perform but the 2 pt calibration performed every 8 hours instead.Each day, the 2pt calibration performed checks every 8 hours from (b)(4) 2014 at 1600 until tech support was called on (b)(4) 2014 at approximately 1530.
 
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Type of Device
SENSOR CASSETTE
Manufacturer (Section D)
RADIOMETER AMERICA
westlake 44145
MDR Report Key4024968
MDR Text Key4879341
Report NumberMW5037780
Device Sequence Number1
Product Code CGA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number945-714
Device Lot Number205624
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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