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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 10.1.2
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
This issue is being further investigated by merge healthcare. A supplemental report will be submitted once the investigation is complete.
 
Event Description
Merge hemodynamics displays, 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) 2019, a customer contact reported to merge healthcare that during a case, the lab froze, beeping was heard from the patient data module (pdm), and the hemo system booted users out. They had to reboot the computer several times. Subsequently, the patient had to be moved to another lab to complete the case. Initial troubleshooting revealed that the 12 volt was out on the hemo pc. In addition, the customer stated that the pci card was frayed. With merge hemo not capturing physiological data, there was a delay in treatment/diagnosis that could potentially cause harm to the patient. However, there was no allegation of harm or injury to a patient or user as a result of this issue. (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 Key8793254
MDR Text Key154150164
Report Number2183926-2019-00025
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2018
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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