MAUDE Adverse Event Report: ASPYRA, LLC ASPYRA MEDVIEW PACS AND ACCESSNET; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problems Patient Data Problem (3197); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This is a pacs system for medical images.Name of system and vendor is called aspyra.Pacs does not have a warning signal that user is looking at a prior exam versus the current exam.I'm a radiologist and i caught myself several times accidentally looking at the old prior study rather than the new one.This is below industry norms and standards and is extremely dangerous and could result in serious patient hard or death.Cancer lesions and other findings could be accidentally misinterpreted and therefore cause harm.Issue was brought to vendor's attention and they were not alarmed.In fact one of the reps from the company made fun of me and said i should just look at the date on each and every of the hundreds and thousands of images that i review as a radiologist.Also loading of images was extremely slow, often taking several minutes.Industry standard is just a few seconds.This is very inefficient and could indirectly cause errors and patient harm.Vendor seemed to acknowledge there was a vpn issue that could be causing this but did not remedy it and even ignored 3 of my emails trying to alert them to the problem.I have 17 years experience as an md/radiologist and aspyra is by far the worst and most unsafe pacs system i have ever used.The fda must take action.Patient lives are at stake here! i urge the fda to investigate immediately and thoroughly.I also have video evidence of some of the problems that i can share.Thank you.

• Brand Name: ASPYRA MEDVIEW PACS AND ACCESSNET
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): ASPYRA, LLC; jacksonville FL 32256
• MDR Report Key: 17218625
• MDR Text Key: 318139841
• Report Number: MW5118888
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female