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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1200 SERIES 1265; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
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SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1200 SERIES 1265; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH Back to Search Results
Model Number 10321852
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2017
Event Type  malfunction  
Event Description
Rapid lab chemistry analyzers (x2) that are used for testing blood gases, lactate and ionized calcium went down and were not available for use.Extensive troubleshooting efforts were performed without success.Utilized different platform to perform testing.Service called.Unit 1: symptoms reported: n d24 aqc material error.Problem: reagent flow errors.Resolution: leak test passed.No flow errors found.System currently operational.Unit 2: n d5 ca++/d3 na/k.Problem: aqc prime errors.Resolution: replaced co-ox sample chamber.System operational.
 
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Brand Name
RAPIDLAB 1200 SERIES 1265
Type of Device
ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
115 norwood park s
norwood MA 02062
MDR Report Key7024217
MDR Text Key91785870
Report Number7024217
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10321852
Device Catalogue Number05063769
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2017
Event Location Other
Date Report to Manufacturer11/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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