MAUDE Adverse Event Report: GE ULTRASOUND KOREA, LTD. LOGIQ P5 PRO BT11; ULTRASONIC IMAGING SYSTEM

Model Number LOGIQ P5

Device Problem Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

No patient involved udi: pre-compliance, there is no udi.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.(b)(4).Ge healthcare (gehc) became aware of an isolated customer contact platform which did not correctly categorize certain china-based customer calls.Gehc's investigation into the issue identified that some china-based customer calls were not considered for complaint evaluation if the customer did not retain a service or warranty contract, and the customer also did not accept a quote for service from gehc.As part of gehc's investigation, this specific call record was determined to be a reportable event and is being reported outside of the 30-day reporting timeline.This process non-conformance is being addressed via gehc's capa system to: report any appropriate records/events which have not been reported as a result of this issue.Prevent future occurrence.Additionally, the customer contacted gehc about one month after the initial report ((b)(6) 2020) and reported that the system would not start up.The power supply was replaced to correct this issue.

Event Description

The user contacted gehc and reported that the power supply burned.There was no report of patient involvement.

• Brand Name: LOGIQ P5 PRO BT11
• Type of Device: ULTRASONIC IMAGING SYSTEM
• Manufacturer (Section D): GE ULTRASOUND KOREA, LTD.; 9, sunhwan-ro 214beon-gil; jungwon-gu; seongnam-si 462-8 07; KS 462-807
• Manufacturer (Section G): GE ULTRASOUND KOREA, LTD.; 9, sunhwan-ro 214beon-gil; jungwon-gu; seongnam-si 462-8 07; KS 462-807
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 12334585
• MDR Text Key: 267017327
• Report Number: 9710090-2021-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K101878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOGIQ P5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1