Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERGE HEALTHCARE MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 11.1.3
Device Problem Loss of Data (2903)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2020
Event Type  malfunction  
Event Description
Merge unity pacs is a medical image, and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On 11/05/2020, a customer contacted merge healthcare to inform us that they were unable to view an exam report from a recent exam.Merge healthcare determined upon investigation that the report saved but failed to upload.Logs were not available for review.A blank report document was manually placed in the folder and the report was re-dictated, and subsequently viewable as expected.This site has regular and persistent network issues that affect report uploads.No further action is necessary at this time.This has the potential to delay patient treatment, and/or diagnosis.There have been no reports of patient injury, or harm as a result of this issue.Reference complaint: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MERGE UNITY PACS
Type of Device
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 59029
MDR Report Key10896943
MDR Text Key218241915
Report Number2183926-2020-00051
Device Sequence Number1
Product Code LLZ
UDI-Device Identifier00842000100058
UDI-Public(01)00842000100058(10)11.1.3.16683(11)190626
Combination Product (y/n)N
PMA/PMN Number
K041935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11.1.3
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-