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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 9.40.3
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2017
Event Type  malfunction  
Manufacturer Narrative
Troubleshooting efforts were made between the customer and merge healthcare over the phone and through remote access. It was determined that there was an issue with the lava serial card. A replacement lava serial card, dual port pcie was sent to the customer on 28jun2017. Further follow up with the customer determined that the lava serial card was installed and no further issues of freezing or buzzing were reported. The faulty unit was scrapped onsite by the customer. Therefore, no further investigation could be performed.
 
Event Description
Merge hemodynamics monitors, 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 reported to merge healthcare that on (b)(6) 2017, the patient data module (pdm pb-1000) was buzzing and froze during testing. The coil cable was replaced and merge hemodynamics was working as expected. Additional follow up with the customer found that on (b)(6) 2017, during a procedure, the hemo monitor froze again and they were not able to get data from the hemo monitor. Subsequently, an external electrocardiogram (ekg) monitor was used in addition to manual charting. The procedure was then completed successfully. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key6746091
MDR Text Key81196045
Report Number2183926-2017-00158
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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