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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 10.0.1
Device Problems Failure to Transmit Record (1521); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2017
Event Type  malfunction  
Manufacturer Narrative
During troubleshooting efforts with hemo support, it was noted that the system needed to be rebooted properly. Hemo support walked the customer through rebooting the hemo system properly: hemo/client then client/hemo. The client pc was logged back in and it was confirmed that the buttons were no longer grayed out. This problem has been addressed and was corrected in version, merge hemo 10. 2 (per field action 2183926-02/15/2016-041-c, z-1091-2017, res 76214). Merge healthcare documentation shows that the customer's parent account was notified of this issue on 10jun2016 (document id (b)(4)).
 
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. The customer reported to merge healthcare on (b)(6) 2017 that during a case, the buttons on the client pc ((b)(4)) were grayed out, therefore another workstation was used to document vitals. During troubleshooting efforts with hemo support, both the hemo monitor pc and the client pc were rebooted while the patient was on the table. In addition, a third party monitoring device was used to monitor the patient. With merge hemo not capturing physiological data, the device is not functioning as expected, therefore, could cause harm to the patient. (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 Key7077612
MDR Text Key94650760
Report Number2183926-2017-00207
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
Remedial Action Recall
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1091-2017

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