MAUDE Adverse Event Report: SEE H10 LOGIQ E9; ULTRASONIC PULSED DOPPLER IMAGING SY

Model Number 5205000-9

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Ge medical systems ultrasound & primary care diagnostics llc, power cord identification: model h4000za, catalog# 5148381.(b)(4).The complaint investigation concluded a portion of the system-end of the power cord separated due to wear and tear, and it confirmed the injury was minor.At that time the complaint investigation was concluded.Then in march of 2018, a separate investigation was performed for a report of a portion of the system-end of a power cord separating unexpectedly, and for which did not result in an injury/event because it was not energized.The results of the second investigation conclude a problem with process control by the supplier of the power cord, and the likelihood of harm associated with this failure is unlikely.A corrective action for the assembly process has been initiated, and quality controls have been implemented.

Event Description

Internally to ge, a portion of the system-end of a logiq e9 power cord had separated unexpectedly while energized and the user¿s finger contacted an energized conductor causing a minor shock resulting in a minor burn to the finger of the user.

• Brand Name: LOGIQ E9
• Type of Device: ULTRASONIC PULSED DOPPLER IMAGING SY
• Manufacturer (Section D): SEE H10; 9900 innovation drive; wauwatosa, WI
• Manufacturer Contact: joseph tamblyn ; 9900 innovation drive; mail drop: rp-2138; wauwatosa, WI
• MDR Report Key: 7396980
• MDR Text Key: 104761738
• Report Number: 3005860720-2018-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K163077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5205000-9
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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