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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 V10.3
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
Customer called and stated that a report in merge cardio looked as if it was confirmed but it was actually just qc'd. Merge healthcare technical support was able to resolve this issue by changing the confirmation state in the database back to qc. This change of status in the database allows the report to be read by a physician. Technical support was unable to troubleshoot this issue for root cause because, at the time of investigation, no recent report change/status logs were left to be investigated. These older transaction logs had been truncated due to their age and were replaced with more recent transaction history information. Merge healthcare personnel have made several attempts to contact the customer for additional information regarding the reports incorrect status, but the customer has not yet responded. If additional information is provided from the customer or if root cause can be determined a supplemental report will be filed.
 
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 called merge cardio support stating there was a report was in confirmed status when it was actually only qc status. Qc reports with the status of confirmed could lead to delay of treatment as the report has not actually been read by a physician. The incorrect status of the report may not be readily apparent to a user. There has been no allegation of an injury or impact to a patient as a result of this issue. Reference complaint-(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
meg mucha
900 walnut ridge dr.
hartland, WI 53029
2629123514
MDR Report Key8470571
MDR Text Key141087098
Report Number2183926-2019-00010
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
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2017
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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