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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER, PRODUCT CODE: DQK

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER, PRODUCT CODE: DQK Back to Search Results
Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1
Device Problems Failure to Transmit Record (1521); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
During troubleshooting efforts with the customer and merge technical support, the patient data module (pdm) was tested with the testplug and the pdm was able to capture pressures on all four ports. The customer reported that they would replace their cables. Merge healthcare is continuing to follow up with the customer for additional patient information and resolution of event. If further information is received from the customer, a supplemental report will be submitted. According to hemo-(b)(4), merge hemo 10 user manual, p. 58: channel 1 through 4 - allows the user to select a location label for recording invasive pressures. This includes setting up and selecting pressure labels to allow for common recordings to be captured. If a transducer or cable is not connected, the affected channel(s) will be grayed out. P. 368: problem: invasive pressure readings and waveforms are not displayed on the hemo monitor. Solution: possible solutions include proper connection of the transducer cable into the pdm for the necessary pressure channel, the transducer cable connection into the customer-supplied transducer, and the integrity of the air-free line to enable a measurement from the most distal catheter location to the hemo screen. Ensure the correct pressure channel is selected for display, and on the correct scale. Additionally, fluid such as saline or contrast at a connection point may compromise a secure fit or provide erroneous values for display. Consider replacing: 1. Transducer cable from pdm, 2. Customer-supplied transducer kit, or checking placement of stopcocks to 'open' or 'closed' as appropriate.
 
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. A customer reported to merge healthcare on (b)(6)2017, that during a procedure, all pressure channels were grayed out. The site did report that they were only able to get a mean pressure. As a result of the pressure channels being greyed out, the user stated that they could not perform the study correctly. No additional information from the customer was provided. With merge hemo not capturing physiological data, there is a potential for a delay in treatment and/or incorrect treatment that could cause harm to the patient. At this time there is no indication that any patient harm occurred. Reference complaint number (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER, PRODUCT CODE: DQK
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
MDR Report Key6796523
MDR Text Key83206916
Report Number2183926-2017-00170
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 Biomedical Engineer
Type of Report Initial
Report Date 07/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.4 PATCH 1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
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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