MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE VERSIONS 4.4.000; SYNAPSE PACS

Model Number SYNAPSE 4.4.000

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

This medical device report is being submitted in an abundance of caution.When the report was first received and investigated, it was determined that the loss of historical images was not a malfunction that had the potential for serious injury or death since the diagnosis and treatment decision had already been made.It was realized later that if these images were required for comparison to new images for a patient, e.G., to determine effectiveness of treatment or advancement on patient's condition, it is possible that, if the historical images were not available, a treatment decision may be made that is not the most effective.Customer notification letters to synapse 4.4.0xx users were mailed on may 10, 2016.A copy of the letter is attached.A correction report in accordance with 21 cfr part 806 will be submitted to the agency on or before may 24, 2016.

Event Description

Customer reported that synapse was unable to display image files and the "image not loaded" message was displayed.Subsequent inspection by service personnel identified the images were no longer in the database.

• Brand Name: SYNAPSE VERSIONS 4.4.000
• Type of Device: SYNAPSE PACS
• Manufacturer (Section D): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 419 west avenue; stamford CT 06902
• Manufacturer (Section G): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 419 west avenue; stamford CT 06902
• Manufacturer Contact: peter altman ; 419 west ave; stamford, CT 06902 ; 2036023576
• MDR Report Key: 5657840
• MDR Text Key: 45259565
• Report Number: 2443168-2016-00003
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SYNAPSE 4.4.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 05/16/2016
• 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: N
• Patient Sequence Number: 1