MAUDE Adverse Event Report: PHILIPS ULTRASOUND INNOSIGHT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 989605463521

Device Problem Incorrect Measurement (1383)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

A customer reported their innosight ultrasound system had produced incorrect cardiac measurements for teicholtz calculations in m mode.The issue was obvious to the user and there was no harm to the user or patient associated with this event.

Manufacturer Narrative

An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Manufacturer Narrative

According to the product defect report initiated by philips, the software involved in this issue is owned by a 3rd party supplier, and they confirmed a software bug was the root cause of the issue and has been corrected in a subsequent software version.

• Brand Name: INNOSIGHT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 13311285
• MDR Text Key: 286951199
• Report Number: 3019216-2022-00008
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605463521
• Device Catalogue Number: 795001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2021
• 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