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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 9.40.1
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2016
Event Type  malfunction  
Manufacturer Narrative
It was found through troubleshooting efforts of merge healthcare and the site that the coil cable had become loose and caused the hemo monitor to disconnect. This required the hemo monitor to be rebooted during which time the patient's data was not captured. The hemo user manual, addresses such an occurrence in the general equipment care section with statements such as, "inspect overall physical condition of the system components, peripherals, and interconnecting cables. Perform any corrective actions required. " furthermore, the (b)(4) section states, "question - why isn't the system showing any waveforms or numbers? answer - check for the green light on the pdm and ensure the link is up. Check to see if any cables are disconnected. " based upon the available information, the reported problem was not caused by product defect or malfunction but rather from a human factors issue.
 
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 the hemo monitor "locked up" during an active case. This required the hemo monitor to be rebooted during which time the patient's data was not captured. During internal trending analysis activities conducted (b)(6) 2016, it was found that this complaint meets the criteria as a reportable event to the fda because there was a potential for patient harm. With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment that results in harm to the patient. However, it was indicated that the procedure was completed successfully once the system was rebooted. (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 Key5815837
MDR Text Key50296453
Report Number2183926-2016-00617
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40.1
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 Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2014
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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