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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

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MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS Back to Search Results
Model Number MERGE PACS 7.0.2
Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation found that during implementation of the upgraded version of merge pacs (7. 0. 2) the overwrite future status setting was set to "no. " this setting was intermittently causing newly imported images to not change the study status to "unread. " merge healthcare support resolved the issue by changing the overwrite future status setting to "no. ".
 
Event Description
Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities. On (b)(6) 2016 the customer alleged to merge healthcare that studies were intermittently going to a "read" status after importing. With non-read or non-reviewed studies indicating a read status could potentially lead to a delay in treatment or diagnosis. The customer did not allege an injury, the need for medical intervention, or adverse consequences as a result of this issue. (b)(4).
 
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Brand NameMERGE PACS
Type of DevicePICTURE ARCHIVING COMMUNICATION SYSTEM PACS
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge dr
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge dr.
hartland WI 53029
Manufacturer Contact
mike diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5743880
MDR Text Key48833557
Report Number2183926-2016-00613
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 05/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE PACS 7.0.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2014
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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