MAUDE Adverse Event Report: CARESTREAM HEALTH IMAGE SUITE SOFTWARE V4

Device Problem Patient Data Problem (3197)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Carestream performed an investigation and identified the root cause analysis in capa (b)(4).To mitigate risk to patient from use of the device, a software design change will be implemented in image suite software vmr8 and released in manufacturing.No further reporting is required.

Event Description

When entering the correct id number of a patient with a slash, x-ray images are assigned to a different patient.If the laboratory technician does not notice this immediately, the x-ray images return to the pacs as a study with the wrong name and birth-date number.This issue exists only when a new patient with a slash is entered in the patient id in the database and stored for use later (e.G: xxx/xxx/xxx,xxx.Xxx).Later when the user desires to open a new study and search by name, the name can be seen but when it is retrieved either nothing is retrieved or a different patient is retrieved.The patient list uses a "/" to split names and when the name itself contains a "/", the software fails to split the patient names.

• Brand Name: IMAGE SUITE SOFTWARE V4
• Type of Device: IMAGE SUITE SOFTWARE V4
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester, ny
• Manufacturer (Section G): 1049 RIDGE RD WEST; carestream health; rochester, ny
• Manufacturer Contact: nancy mejias ; 150 verona st; rochester, ny ; 6278533
• MDR Report Key: 10216225
• MDR Text Key: 198138156
• Report Number: 1317307-2020-00003
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K100094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1