Merge Hemo 10.0.4Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842000100010), received between May 14, 2018 and Aug 30, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K082421); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2018Power Problem; Power Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT "???" DISPLAYED ON THE HEMO MONITOR AND THE PDM (PATIENT DATA MODULE) WAS NOT WORKING CAUSED FROM A BLOWN FUSE ON THE 12 V. IT WAS FURTHER REPORTED THAT A PATIENT WAS PRESENT AND WAS UNDER SEDATION CAUSING A DELAY IN TREATMENT TO BE GREATER THAN FIFTEEN (15) MINUTES WHILE THE FUSE WAS CHANGED OUT AND THE HEMO SYSTEM REBOOTED. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE THE FUSE WAS REPLACED AND THE HEMO APPLICATION WAS REBOOTED. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831482 ↗
• MalfunctionAug 22, 2018Electrical /Electronic Property Problem; Failure to Power Up; Smoking; Temperature Problem; Electrical /Electronic Property Problem; Failure to Power Up; Smoking; Temperature Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON JULY 26, 2018, THE CUSTOMER CONTACT REPORTED THAT THE UNINTERRUPTED POWER SOURCE (UPS) IN LAB 1 STOPPED WORKING AND STARTED SMOKING. THERE WAS NO PATIENT ON THE TABLE DURING THIS TIME AND THE UPS WAS SWAPPED OUT. THE CUSTOMER CONTACT FURTHER REPORTED THAT TWO EMPLOYEES SOUGHT MEDICAL ATTENTION AS A RESULT OF THE SMOKING UPS. THERE WAS NO ADVERSE EVENT REPORTED, HOWEVER, FURTHER FOLLOW UP HAS BEEN SENT TO THE CUSTOMER FOR ADDITIONAL INFORMATION ON THE USER/EMPLOYEE IMPACT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE HEALTH EFFECTS OF SMOKE INHALATION IS DEPENDENT ON HOW MUCH HAS BEEN BREATHED AND FO

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7807977 ↗
• MalfunctionAug 20, 2018Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE CUSTOMER CONTACTED MERGE HEALTHCARE TECHNICAL SUPPORT ON JULY 23, 2018 TO REPORT THAT ON (B)(6) 2018, THE HEMO SYSTEM FROZE DURING A CASE. SUBSEQUENTLY, USERS WERE UNABLE TO TAKE THE PATIENT'S ELECTROCARDIOGRAM (ECG) WAVEFORM DATA AND THEY WERE NOT ABLE TO MANUALLY ENTER VITALS INTO THE CLIENT PC. AS A RESULT, THE HEMO SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED ONCE THE HEMO SYSTEM CAME BACK ONLINE. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT AND/OR DELAY IN TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, THERE WAS NO ALLEGATION OR INDICATION OF HARM TO THE PATIENT AS A RES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796775 ↗
• MalfunctionAug 12, 2018Power Problem; Power Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE PERSON ICON LOCATED WITHIN THE HEMO APPLICATION WAS FLASHING INDICATING A DISCONNECTION BETWEEN THE HEMO MONITOR AND PDM (PATIENT DATA MODULE). THIS OCCURRED DURING A PROCEDURE AND RESULTED IN THE USE OF PORTABLE BLOOD PRESSURE MONITORING AND THIRD PARTY EQUIPMENT TO CAPTURE THE PATIENT'S INVASIVE PRESSURES. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REVEALED THAT THE PROBLEM OCCURRED TWICE ON DIFFERENT DAYS, (B)(6) 2018. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, THE CUST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7775821 ↗
• MalfunctionAug 12, 2018Communication or Transmission Problem; Intermittent Communication Failure; Communication or Transmission Problem; Intermittent Communication Failure

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, THE CUSTOMER CONTACT REPORTED THAT CATH LAB 2 WAS HAVING CONNECTIVITY ISSUES WHICH WAS NOTED BY FLASHING ARROWS. IT WAS REPORTED THAT THIS OCCURRED PRIOR TO THE START OF A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) CASE, HOWEVER THE PATIENT WAS ALREADY SEDATED AND BEING ACTIVELY MONITORED. AS A RESULT, THE HEMO MONITOR PC WAS REBOOTED AND THE CASE WAS COMPLETED ONCE HEMO CAME BACK ONLINE. IN ADDITION, THE PATIENT'S HEART RATE (HR), RHYTHM, AND BLOOD PRESSURE (BP) WAS CAPTURED USING A 3RD PARTY MONITORING DEVICE. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT AND/OR DELAY IN TRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7775819 ↗
• MalfunctionAug 8, 2018Power Problem; Power Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE PERSON ICON LOCATED WITHIN THE HEMO APPLICATION WAS FLASHING INDICATING A DISCONNECTION BETWEEN THE HEMO MONITOR AND PDM (PATIENT DATA MODULE). THIS OCCURRED DURING A PROCEDURE AND RESULTED IN THE USE OF PORTABLE BLOOD PRESSURE MONITORING AND THIRD PARTY EQUIPMENT TO CAPTURE THE PATIENT'S INVASIVE PRESSURES. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REVEALED THAT THE PROBLEM OCCURRED TWICE ON DIFFERENT DAYS, (B)(6) 2018. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, THE CUST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7766076 ↗
• MalfunctionJul 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, THE CUSTOMER CONTACT REPORTED THAT THE ELECTROCARDIOGRAM (ECG) SWEEP SPEED TRACINGS CHANGED UNEXPECTEDLY. IT WAS REPORTED THAT IN THE MIDDLE OF A CASE WITHOUT ANY INITIATED CHANGE FROM USER, THE HEART RATE WENT FROM 70 BEATS PER MINUTE (BPM) TO 40 BPM, HOWEVER THE COUNTING STAYED THE SAME. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH AN INTERVENTION WHEN IT WAS NOT NEEDED. IT WAS NOTED THAT LEAD 2 WAS OFF, THEREFORE, THEY CHANGED THE SWEEP SPEED THEN CHANGED IT BACK AND THE ECG TRACING AND HEART RATE WENT BACK TO NORMAL. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT AS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7725310 ↗
• MalfunctionJul 17, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT A FREEZING ISSUE OCCURRED DURING TWO (2) BACK-TO-BACK PROCEDURES. DURING THE FIRST OCCURRENCE, THE FREEZING ISSUE PREVENTED A PATIENT'S BLOOD PRESSURE VALUES FROM BEING DISPLAYED. BOTH THE HEMO MONITOR AND CLIENT PC WERE REBOOTED AFTER THE PATIENT HAD BEEN SEDATED AND ACTIVE MONITORING HAD STARTED. DURING THE SECOND OCCURRENCE, THE MEDICAL STAFF REALIZED IT WAS AN NIBP (NON-INVASIVE BLOOD PRESSURE) ISSUE AND SUBSEQUENTLY USED A MANUAL BLOOD PRESSURE CUFF TO OBTAIN THE PATIENT'S BLOOD PRESSURE VALUES. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR DELAY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7696203 ↗
• MalfunctionJul 17, 2018Communication or Transmission Problem; Intermittent Communication Failure; Communication or Transmission Problem; Intermittent Communication Failure

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC ON (B)(6) 2018, THE CUSTOMER CONTACT REPORTED THAT THE CLIENT PC AND THE HEMO PC LOST CONNECTION TO ONE ANOTHER IN LAB 3. IT WAS REPORTED THAT THE PATIENT WAS MOVED TO ANOTHER LAB, HOWEVER, IT IS UNKNOWN IF THIS OCCURRED PRIOR TO THE START OF THE CASE OR DURING. ON (B)(6) 2018, THE CUSTOMER FURTHER REPORTED THAT THE CLIENT PC AND THE HEMO PC LOST CONNECTION AGAIN DURING A CASE, WHILE THE PATIENT WAS ALREADY SEDATED. AS A RESULT, THE HEMO SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED ONCE HEMO CAME BACK ONLINE. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR INCORRECT TREATMENT THAT COULD CAUSE HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695305 ↗
• MalfunctionJun 27, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; Failure to Transmit Record; Device Issue; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Failure to Transmit Record; Device Issue

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT A POWER ISSUE OCCURRED IN THE MIDDLE OF A PROCEDURE RESULTING IN THE LOSS OF CAPTURING PHYSIOLOGICAL DATA. THE CUSTOMER REPORTED THAT BOTH THE HEMO MONITOR AND CLIENT PC WERE REBOOTED; AFTERWARDS THE HEMO MONITOR WOULD NOT POWER ON. SUBSEQUENTLY, THIRD PARTY MONITORING WAS USED, HOWEVER THE BRAND/TYPE WAS NOT DISCLOSED TO MERGE HEALTHCARE. IT WAS ALSO REPORTED THAT THERE WAS A SLIGHT DELAY WHILE CONNECTING THE EXTERNAL EQUIPMENT. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR DELAY IN TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, IT WAS REPOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643364 ↗
• MalfunctionMay 14, 2018Device Issue; Device Operational Issue; Device Issue; Device Operational Issue

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. A MERGE HEMO CUSTOMER REPORTED TO HEMO TECHNICAL SUPPORT ON (B)(6) 2018, THAT DURING A CASE THE PEOPLE/PERSON ICON ON THE HEMO SCREEN STARTED FLASHING RED INDICATING A COMMUNICATION ISSUE WITH THE PATIENT DATA MODULE (PDM). THE HEMO MONITOR PC WAS REBOOTED ONCE PRIOR TO THE START OF THE CASE AND ONCE DURING THE CASE WHILE THE PATIENT WAS BEING ACTIVELY MONITORED AND SEDATED. BOTH INVASIVE AND NON-INVASIVE PRESSURES WERE BEING MONITORED AND A 3RD PARTY MONITORING DEVICE WAS NOT USED WHILE THE HEMO MONITOR WAS REBOOTED. THERE WAS NO INDICATION OF PATIENT HARM AS A RESULT OF THIS ISSUE. HOWEVER, WITH MERGE HEMO BEING REBOOTED AND NOT CAPTURING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7513316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082421. One submission often covers many models, so check the product and lot details in each record.

• Z-1457-2017 · Apr 4, 2016 · Terminated
  Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
• Z-1778-2017 · Apr 4, 2016 · Terminated
  Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a
• Z-1091-2017 · Mar 28, 2016 · Terminated
  Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
• Z-2707-2017 · Mar 10, 2016 · Terminated
  The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
• Z-0554-2016 · Oct 26, 2015 · Terminated
  Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a c
• Z-1203-2017 · May 31, 2015 · Terminated
  The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
• Z-1923-2017 · Mar 30, 2015 · Terminated
  Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module
• Z-2347-2015 · Jan 21, 2015 · Terminated
  Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monit
• Z-0143-2015 · Sep 29, 2014 · Terminated
  Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are con
• Z-0665-2017 · Apr 30, 2014 · Terminated
  Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is fo
• Z-2341-2016 · Jul 2, 2012 · Terminated
  Merge HEMO software.