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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 V10.1.2
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2016
Event Type  malfunction  
Manufacturer Narrative
Merge healthcare support assisted the customer and enabled the study to be in a state where it could be reviewed and confirmed by the physician. Upon further investigation, it was determined via audit trail, that the physician that ended up confirming the report did in fact, review the study and attempt to report on the study on the same day that the study was performed on the patient. The study images were available even though the clinical report was unable to be completed without assistance from merge support. A workaround could have been used where the study was transcribed through the customer's emr system, if needed. The root cause of the customer's reported problem is currently under investigation by merge healthcare. (b)(4). 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) 2016, a customer reported to merge healthcare that a clinical report was displaying "confirmed" status when in fact it had not yet been confirmed and the doctor was unable to report on the study. There is a potential for a delay in care that may lead to harm if an incorrect confirmation status prevents a physician from completing their report of a patient's study. However, the customer has not indicated any harm to a patient. Reference complaint number (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 Key5989385
MDR Text Key56001125
Report Number2183926-2016-00747
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 Hospital Service Technician
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 08/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.1.2
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 Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
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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