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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH IMAGE SUITE SOFTWARE V4

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CARESTREAM HEALTH IMAGE SUITE SOFTWARE V4 Back to Search Results
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.

 
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Brand NameIMAGE SUITE SOFTWARE V4
Type of DeviceIMAGE 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 Key10216225
MDR Text Key198138156
Report Number1317307-2020-00003
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeEZ
PMA/PMN NumberK100094
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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