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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS

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MERGE HEALTHCARE MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS Back to Search Results
Model Number MERGE CARDIO V9.0.8
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2016
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2016, the dchu contacted the customer to investigate for patient safety issues. Customer stated that the incorrect value was readily apparent to the physicians during diagnosis and at that time the physicians were able to manually correct the incorrect value prior to confirming the final report and no patients were harmed or misdiagnosed due to the incorrect measurement mapping. The incorrect measurement mapping was corrected by merge healthcare and validated by the customer.
 
Event Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. On (b)(6) 2016, a customer contacted merge healthcare and stated that a diagnostic measurement taken by their modality was importing into the incorrect node within the clinical reporting tool. Due to an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm. The incorrect value was readily apparent to physicians and there is no information to suggest that a patient was harmed as a result of this issue. (b)(4).
 
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Brand NameMERGE CARDIO
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
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 dr.
hartland, WI 53029
2629123570
MDR Report Key5969056
MDR Text Key55326080
Report Number2183926-2016-00736
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V9.0.8
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 Received08/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2016
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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