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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 9.30
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2016
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 01aug2016. Merge technical support attempted to reach the customer on three separate occasions to troubleshoot their reported issue. However no attempts were successful in reaching the customer. A quick guide for using st. Jude medical pressure wire aeris is provided to customers who use the optional feature, ffr (fractional flow reserve). The following steps are provided to medical staff: verify the pressurewire receiver is plugged into p3. Double click or drag ffr procedure from template into chron log. Label/select aortic channel as pressure 1 and distal channel as pressure 3. Label/select aortic location as 'ao' and distal location as 'wire' or 'dst-a'. (this labeling will allow the distal location pressure tracing to display in a pink color to differentiate it from the ao in red). Zero pressure channel 1 and zero pressure channel 3. Flush the pressurewiretm aeristm in the hoop. Press quickly on the center connect button to activate receiver. Push the sliding button on the pressurewiretm aeristm forward to zero and connect with receiver. Select 'show' in the ffr action editor and the ffr mode will activate. Click on equalize once the pressurewiretm aeristm is advanced outside the guide and proximal to the lesion. Verify you get 1. 0 before proceeding. Verify the wire introducer is removed and the toughy is closed. Start recording after the pressure wiretm aeristm is advanced beyond the lesion press stop when you are finished or allow the recording to continue the entire time set for the recording. Note: the "live" ffr value is an average of beats selected in settings>pressure tab and may not reflect the lowest individual ffr value during the "live" recording. A value of '0' in settings will average the recording ffr value over 6 seconds. After the recording is complete the computer will scan the entire ffr waveform recording and select the lowest individual ffr value on the waveform. Review the recorded ffr waveform and if needed, select the desired ffr value by moving the ffr transition label at the bottom of the recording left or right. Additional beats may be added by a single left click on any individual beat in the recording. All highlighted beats will be used in the averaged ffr value.
 
Manufacturer Narrative
Troubleshooting efforts are still underway to determine the reported problem. When more information becomes available, a supplemental report will be submitted.
 
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 (b)(6) 2016, a customer reported to merge healthcare that negative pressure waveforms were present during an active case after the fractional flow reserve (ffr) device was zero pressured. Information obtained from the customer revealed that the negative pressure waveforms were intermittent when used with the ffr 3rd party device. With merge hemo not capturing physiological data, there is a potential for incorrect treatment that results in harm to the patient. However, the customer reported that the procedure was completed successfully without using ffr. (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 Key5835910
MDR Text Key260275234
Report Number2183926-2016-00667
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,Followup
Report Date 07/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
Treatment
ST. JUDE FFR DEVICE (ARIS)
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