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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 10.0.1
Device Problems Failure to Zero (1683); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2016
Event Type  malfunction  
Manufacturer Narrative
Communication between merge healthcare and the customer revealed that the site does not routinely zero channel 3 and is likely that the ffr action editor was set incorrectly. It was also noted that the third party transducer was subsequently replaced. Hemo 10 user manual, addresses the potential for such an occurrence by statements such as, "in order to calculate ffr, the blood pressure proximal to a lesion must also be measured. A standard pressure transducer device is required. The standard pressure transducer used in the cardiac catheterization laboratory converts a column of fluid (pressure of the patients' arterial or venous system) into an electronic signal using a strain gauge that is then displayed on the hemodynamic monitor. The transducer should be zeroed at the beginning of every study as a precaution whenever a pressure displayed on the screen is suspect, or any time a new transducer is connected to the hemodynamic system. " for this reason, conclusions code (failure to follow instructions) was used.
 
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 integrated ffr (fractional flow reserve) would not equalize during a procedure. This resulted in a 15 minute delay. 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 using a third party ffr device. Reference complaint number (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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key5852690
MDR Text Key51346157
Report Number2183926-2016-00679
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 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2015
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: 08/08/2016 Patient Sequence Number: 1
Treatment
VOLCANO FFR TRANSDUCER
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