MAUDE Adverse Event Report: PHILIPS ULTRASOUND HD7 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number 795078

Device Problem Poor Quality Image (1408)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Once additional information is obtained, a follow up report will be submitted.

Event Description

A customer reported blood flow is intermittently insensitive when doing cardiac work and heart function cannot be measured.It could not be determined if the device was being used in a critical procedure.There was no adverse patient or user impact associated with this event.

Manufacturer Narrative

Further investigation determined that this was not a system malfunction.The issue was a matter of clinical application support, and no misdiagnosis occurred.The issue was transferred to the clinical department for resolution.

• Brand Name: HD7 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, 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: 16063340
• MDR Text Key: 308195041
• Report Number: 3019216-2022-00118
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 795078
• Is the Reporter a Health Professional?: No
• Type of Device Usage: A
• Patient Sequence Number: 1