MAUDE Adverse Event Report: CARESTREAM HEALTH INC TOUCH ULTRASOUND

Device Problem Computer Software Problem (1112)

Patient Problem No Information (3190)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

Carestream health inc., notified sites with impacted devices on (b)(6 2016 and that until a software correction is made, customer sites should not use the 3 distance generic volume tool but instead use the toolbox volume calculation function, which is working correctly,.A software update is currently being tested and validated and will be deployed as a correction to the field when ready.Carestream health inc., will submit notice of a correction to the fda as soon as possible, but certainly before (b)(6) 2016.

Event Description

Based on feedback from product demonstrations, carestream health inc has been made aware of a software defect with incorrect volume calculation when using the 3 distance generic volume tool.

Manufacturer Narrative

Carestream health has investigated this adverse event incident and has determined this is a software defect which requires a correction to the install base.A report of corrections and removals notification was submitted to the fda on june 24, 2016.

• Brand Name: TOUCH ULTRASOUND
• Type of Device: TOUCH ULTRASOUND
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEATLH INC; 1049 ridge rd west; rochester NY 14615
• Manufacturer Contact: gina maiolo ; 150 verona; rochester 14608 ; 5856278230
• MDR Report Key: 5720420
• MDR Text Key: 47234511
• Report Number: 1317307-2016-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other