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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 10.0.3 PATCH 1
Device Problems Incorrect Measurement (1383); Failure to Zero (1683); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
The unit has not been returned by the customer to merge healthcare for evaluation as of 23may2017. 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) 2017, a customer reported to merge healthcare that a pressure chanel would show real pressures. It was reported that the patient was moved to another room onsite. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. However, the procedure was completed successfully once the patient was moved to another lab. (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 Key6586823
MDR Text Key75817340
Report Number2183926-2017-00113
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 04/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMERGE HEMODYNAMICS 10.0.3 PATCH 1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
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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