MAUDE Adverse Event Report: LUCEA; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568602971

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 17th of august 2020 getinge became aware of an issue with one of device- lucea 10.As it was stated it has been discovered that the suspension arm showing early signs of breakage what could led to detachment from the main tube.We were not able to established condition of the cylinder pin, therefore we assume the worst case scenario when the pin is broken.There was no injury reported however we decided to report the issue in abundance of caution as such situation may lead to serious injury upon reoccurrence.Manufacturer's reference number (b)(4).

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of device- lucea 10.As it was stated it has been discovered that the suspension arm showing early signs of breakage what could led to detachment from the main tube.We were not able at the beginning to establish condition of the cylinder pin, therefore we assume the worst case scenario when the pin is broken.It was established later that horizontal part broke off completely from the vertical one.There was no injury reported however we decided to report the issue in abundance of caution as such situation may lead to serious injury upon reoccurrence.It was established that when the event occurred, the light did not meet its specification as it has been found that breakage of the weld occurred and it contributed to event.In the time when the event occurred the device was not used for patient treatment.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.Performed evaluation of returned parts revealed that although the cylinder pin, preventing the tube from falling out, was in its dedicated place however it has been broken in two places, what resulted in its function to be lost.This, in the worst case scenario, could cause the tube being completely uncoupled from the main axis and prevented from falling only by the harness cable.A root cause analysis was performed by the subject matter expert and supported with review of faulty parts received from the market.The conclusion is pointing to misuse being the main cause of pin breakage.When the arm of the device (oriented 90o to the main arm) is moved without loosening the clamping knob to release the pivot as described in the user manual 01701en05 page 29 (positioning the light), a strong shearing effect is applied on the cylinder pin.With repetitive motions like this over time, it is probable that the pin can break.We believe that this type of our devices are performing correctly in the market.We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided.

• Brand Name: LUCEA
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• MDR Report Key: 10435818
• MDR Text Key: 204073332
• Report Number: 9710055-2020-00338
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568602971
• Device Catalogue Number: ARD568602971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1