MAUDE Adverse Event Report: INTRASIGHT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 797403

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.Not applicable for this system.Not applicable for this system.The system was analyzed at the customer facility by the manufacturer's field service engineer (fse).The fse was able to verify customer reported issue.The fse moved the mmtsm device to aux3 port and the system is operating as intended.The health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: 2199 (no health consequences or impact).Do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that during use of the manufacturing system, the multi-modality touch screen monitor (mmtsm) display was lagging causing the playback to display inaccurate measurements.The patient was successfully treated using the main monitor in the control room.This product problem is being submitted because recurrence of the malfunction may cause or contribute to an adverse event if inaccurate measurement data was used.

Manufacturer Narrative

Internal reference: (b)(4).Block h6: added codes 953 (screen) and 2199 (no health consequences or impact).

• Brand Name: INTRASIGHT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 11778689
• MDR Text Key: 249212277
• Report Number: 2939520-2021-00024
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(90)300000437313
• Combination Product (y/n): Y
• PMA/PMN Number: K190078
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 797403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 84