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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535); High Readings (2459); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2019
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. [fda_medwatch_report_mw5084968].
 
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, the customer contact reported that during an urgent case, pressure values were incorrect. No complicated pressures were needed therefore, a portable 3rd party system was used to complete the case. Additional information was received on (b)(6) 2019 (from medwatch report, mw5084968) stating that the pressure readings were doubled causing a patient to be transferred to another lab. Subsequently, the patient was re-prepped and the procedure was completed after a 30 minute delay. Additional access was required due to the potential for contamination from the original access site during the patient move. Please reference attached medwatch report mw5084968 for additional information. 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
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key8532155
MDR Text Key145617692
Report Number2183926-2019-00016
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2019
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

Patient Treatment Data
Date Received: 04/19/2019 Patient Sequence Number: 1
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