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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 9.20
Device Problems Battery Problem (2885); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 01/13/2017
Event Type  malfunction  
Manufacturer Narrative
The faulty ups unit was returned by the customer to merge healthcare on (b)(6) 2017 for evaluation. The results showed that the batteries were enlarged and bloated but no fluid leak was identified. Upon replacing the batteries, the unit passed all qc testing and was then sent to service stock.
 
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 the ups (uninterrupted power supply) was hot and emitted a burning odor. Information obtained from the customer revealed that the user shutdown the computers, removed the ups unit, and bypassed the power supply to the hospital power outlets. It was reported that no patient was present when the ups failed. If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns. However, there was no report of user harm. (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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key6313311
MDR Text Key66877213
Report Number2183926-2017-00033
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
Report Date 01/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2012
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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