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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 V11.1.1
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
The customer's reported problem is currently under investigation by merge healthcare. The customer confirmed there were no allegations of patient harm due to this issue. This is still being investigated by support and development. When more information becomes available, a supplemental report will be submitted.
 
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) 2019, a customer contacted merge healthcare and stated that diagnostic measurements (mr vena contracta and tr vena contracta) that were never taken on the modality were populating the cardio clinical report. Due to an incorrect values displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm. (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 walnutridge dr
hartland, wi WI 53029
Manufacturer Contact
brian bell
900 walnutridge dr
hartland, wi, WI 53029
2629123514
MDR Report Key9548544
MDR Text Key196245177
Report Number2183926-2019-00028
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
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V11.1.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2019
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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