MAUDE Adverse Event Report: GE ULTRASOUND KOREA, LTD. GE LOGIQ P6; DIAGNOSTIC ULTRASOUND SYSTEM

Model Number H46172LL

Device Problems Circuit Failure (1089); Fail-Safe Problem (2936); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The logiq p6 that was producing the warm probe was sent to ge for evaluation & repair where both the power supply that drives acoustic output was replaced and software associated with the hardware change was updated.This corrected the issue with this specific device.Further investigation by ge identified a component failure within the power supply that drives acoustic output which produced a higher than expected voltage.Additionally, the revision of software in the logiq p6 with this issue does not contain a protection measure to shut off acoustic output in the event of the power supply over-voltage failure which is found in newer revisions of logiq p6s.Therefore, the evaluation of the investigation shows a new failure mode for the power supply occurred and the system did not contain a revision of software with the safety feature to turn off acoustic output in the event of a power supply over-voltage.The conclusion is that all revisions of logiq p6 with software that does not contain the safety feature are to be updated with the software revision containing the safety feature via a field action.

Event Description

A user reported to ge that a 3sp (probe) is very warm쳌 when used with one of two logiq p6s they own.Additionally, they used a second 3sp probe to evaluate the situation and the same issue occurred with that probe.There was no patient involved with either case.

• Brand Name: GE LOGIQ P6
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): GE ULTRASOUND KOREA, LTD.; 9 sunhwan-ro 214beon-gil; gyeonggi-do; jungwon-gu, seongnam-si 462-8 07; KS 462-807
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2138; wauwatosa, WI
• MDR Report Key: 8237073
• MDR Text Key: 132919520
• Report Number: 9710090-2019-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K073297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H46172LL
• Device Lot Number: 106007SU8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2126677-01/10/19-002-C
• Patient Sequence Number: 1