Automated Blood Coagulation Analyzer CS-2100i 06372511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987562409471), received between Jan 18, 2018 and Aug 1, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2019Thermal Decomposition of Device; Melted; Device Emits Odor; Thermal Decomposition of Device; Melted; Device Emits Odor

  THE USER REPORTED A BURNT ODOR EMANATING FROM THE ANALYZER. THE USER IMMEDIATELY TURNED OFF AND DISCONNECTED THE ANALYZER FROM THE POWER SUPPLY. THERE WAS NO REPORT OF HARM TO THE OPERATOR. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INSPECT THE ANALYZER. THE FSE FOUND MELTING AND CHARRING OF WIRING CORD 3834. WIRING CORD 3834 CONNECTS THE HALL ELEMENT NO. 7 ASSEMBLY TO PCB NO. 1278. THE FSE INSTALLED A NEW SAMPLE TABLE ASSEMBLY, REPLACED THE MIXING MOTORS AND HALL EFFECT SENSORS, ADJUSTED ALL TEMPERATURES AND PERFORMED NECESSARY SAMPLE ARM AND REAGENT ARM ADJUSTMENTS. THE FSE ADJUSTED THE CATCHER TO THE DISPENSING WHEEL, PERFORMED ALL ADJUSTMENTS AND CHECKED THE TEMPERATURE. THE FSE THEN RAN QC AND DEEMED THE ANALYZER OPERATIONAL. PART REPLACEMENT AND EVIDENCE BASED MAINTENANCE RESOLVED THE ISSUE FOR THE USER.

  Patient problems: No Patient Involvement

  MAUDE report 8853077 ↗
• MalfunctionApr 3, 2019Overheating of Device; Smoking; Overheating of Device; Smoking

  A USER IN (B)(6) REPORTED A BURNT ODOR EMANATING FROM THE ANALYZER. THE USER IMMEDIATELY TURNED OFF THE ANALYZER, DISCONNECTED THE POWER, AND CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS. A SIEMENS SERVICE ENGINEER (SE) WAS DISPATCHED THE SAME DAY AND FOUND THE CP UNIT DRIVE OF MOTOR BLOCK ASSEMBLY NO. 126 WAS BURNT, PARTS OF THE MOTOR ENCODER DISC WERE MELTED, A FUSE ON THE POWER SUPPLY (WIRING CORD NO. 5391) WAS BLOWN, AND PRINTED CIRCUIT BOARD (PCB) NO. 1279 WAS DAMAGED. SMOKE WAS OBSERVED; HOWEVER, NO OPEN FIRE WAS OBSERVED. NO USERS SOUGHT MEDICAL ATTENTION DUE TO THE BURNING ODOR. NO USER OR PATIENT HARM OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478205 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS GIVEN A SECOND DOSE OF VITAMIN K BASED ON AN ERRONEOUS HIGH PROTHROMBIN TIME (PT). THE PATIENT RECEIVED AN INITIAL TREATMENT OF VITAMIN K. AFTER TREATMENT, THE PATIENT WAS DRAWN, AND THE SAMPLE WAS ANALYZED GENERATING A HIGH PT RESULT. UPON RECEIPT OF THE HIGH PT RESULT THE PATIENT WAS GIVEN A SECOND TREATMENT OF VITAMIN K. ANOTHER SAMPLE WAS DRAWN AND ANALYZED, GIVING RESULTS WITHIN NORMAL RANGES. THE USER REANALYZED THE PATIENT'S INITIAL SAMPLE TWICE AND NORMAL PT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7204787 ↗