MAUDE Adverse Event Report: ACFA HEALTHCARE IMPAX AGFA HEALTHCARE; INFORMATION SYSTEM, PICTURE ARCHIVING AND COM

Model Number PROLIANT DL320EG8

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  Injury  

Event Description

A single image in a ct series was flipped and saved.When the radiologist made his final interpretation, there was not a significant visual indication that the image had been manipulated.

• Brand Name: IMPAX AGFA HEALTHCARE
• Type of Device: INFORMATION SYSTEM, PICTURE ARCHIVING AND COM
• Manufacturer (Section D): ACFA HEALTHCARE; 112 wade hampton dr; beaufort SC
• MDR Report Key: 6260886
• MDR Text Key: 65313208
• Report Number: MW5067302
• Device Sequence Number: 1
• Product Code: LLZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROLIANT DL320EG8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Weight: 69