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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 V10.0
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
The incorrect measurements were readily apparent to the user and there have been no reports of patient harm due to this issue. Merge healthcare corrected this issue to ensure that the measurement was mapped to the correct location. The correction has been confirmed by the customer. No further action is required or anticipated at this time. (b)(4).
 
Event Description
Merge cardio is used to acquire, store, print, transfer and archive clinical information from hemodynamic and cardiology imaging modalities. Images and studies can be reviewed, annotated, digital calculations and quantitative measurements can be performed in order to generate and store reports. On (b)(6) 2018, 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. However, there was no impact or consequence to the patient. (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 drive
hartland, WI 53029
2629123570
MDR Report Key7454374
MDR Text Key106962049
Report Number2183926-2018-00027
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE CARDIO V10.0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated by Manufacturer? Yes
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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