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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 Problems Failure to Power Up (1476); Power Problem (3010); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
Event Type  malfunction  
Manufacturer Narrative
Both of the faulty ups units were returned by the customer to merge healthcare on 02dec2016 for evaluation. The results showed that the batteries were defective and subsequently replaced. Upon replacing the batteries, the units passed all qc testing and were then sent to service stock. Device labeling, hemo v9. 40 user manual, addresses the potential for such an occurrence with statements such as, "if low voltage is detected, the pdm goes to battery power and an audible alarm sounds. ".
 
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 ups (uninterrupted power supply) was buzzing and caused the hemo application to shut down during two (2) procedures, each in different labs at the site. Information obtained from the customer revealed that upon failure of the ups units, the user immediately plugged the hemo system into a wall outlet and then waited for the system to reboot. The delay was ~10-15 minutes. This resulted in a loss of patient monitoring during the reported delay. If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns. However, the customer confirmed that there were no injuries to the patients or staff. With merge hemo not capturing physiological data, there is a potential for delay of treatment that could cause harm to the patient. However, the customer reported that the procedures were completed successfully once the hemo 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 Key6183834
MDR Text Key62681178
Report Number2183926-2016-00818
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 11/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2016
Was Device Evaluated by Manufacturer? Yes
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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