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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 10.0.3
Device Problems Failure to Transmit Record (1521); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2017
Event Type  malfunction  
Manufacturer Narrative
During troubleshooting efforts, the customer reported to merge technical support that the calculations provided by merge hemo were correct, however the waveforms were weak. Merge technical support advised the customer to switch out the third party catheter and to hang it from an iv pole to reduce noise and interference on the transducer. The attending physician then switched out the catheter and the procedure was completed successfully. The faulty hardware will not be received from the customer since it was third party equipment. (b)(4).
 
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. On june 30, 2017, a customer reported to merge healthcare that a problem occurred while attempting to obtain a patient's thermo co (cardiac output) readings. Subsequently, the patient was moved to another lab after sedation had been initiated to rule out faulty hemo equipment. However, the problem persisted so the attending physician removed the catheter and replaced it with a new one. With merge hemo not presenting physiological data during treatment, there is a potential for delay in care that could result in harm to the patient. However, the customer confirmed that the procedure was completed successfully once the third party catheter was changed out. (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 Key6753211
MDR Text Key81383194
Report Number2183926-2017-00159
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 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.3
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 Received06/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/06/2016
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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