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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 Failure to Power Up (1476); Power Problem (3010); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2016
Event Type  malfunction  
Manufacturer Narrative
The faulty ups was received by merge healthcare on 07nov2016 but has not yet been evaluated. For this reason, (b)(4) (conclusion not yet available-evaluation in progress) was used. 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) 2016, a customer reported to merge healthcare that the ups (uninterrupted power supply) was buzzing and the hemo application was not powering on in the site's (b)(6). 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, no reports were received of staff injury and information obtained indicated that the problem occurred when no patient was present. Additionally, the site has other cath labs for use. 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 Key6126703
MDR Text Key60907227
Report Number2183926-2016-00802
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 10/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.3 PATCH 1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2017
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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