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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 Problem Electronic Property Issue (2928)
Patient Problem No Patient Involvement (2645)
Event Date 03/31/2016
Event Type  malfunction  
Manufacturer Narrative
The suspect hardware component is a ups, tripp lite 1000va, and a replacement was shipped from merge healthcare's (b)(4) site to the customer on 3/31/2016. The actual hardware was returned by the customer. Upon completion of the evaluation, the batteries appeared to have overcharged and expanded to the point of failure.
 
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 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 hemo monitor pc via the serial interface. All data can be shown and monitored on the hemo monitor pc. On (b)(6) 2016, a customer reported to merge healthcare that the uninterrupted power source (ups) batteries had ruptured. A report of ruptured batteries and/or a malfunctioning ups can lead to a potentially hazardous situation for users and/or patients. The customer confirmed that there was no patient involvement and no user harm was reported. (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 Key5622874
MDR Text Key44130501
Report Number2183926-2016-00567
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 03/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2016
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 Manufacturer04/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/13/2018
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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