MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3000; LAMP, SURGICAL

Model Number ARD567902999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 19th november, 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that cover's detachment occurred.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Event Description

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

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that bumper fallen down.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.The technician visited the customer and found that hlx bumper elasticity slightly week.Technician suggested to customer replacement with new one as early as possible.Bumper was removed from light and kept it at biomedical department.It was established that when the event occurred, the surgical light did not meet its specification as detachment of the bumper could be treated as technical deficiency and it contributed to the event.There is no information if upon the event occurrence the device was or was not being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury nor death.The fall of the bumper is due to repeated collisions or a partial repositioning.Tests performed show that the bumper can fall after several violent collisions with the cupolas especially for the single fork configurations (low ceiling height rooms).This corresponds to an abnormal use.Maquet sas modified the bumper to make it harder and thus increase its tightening onto the suspension arm by reducing its elasticity.However, in specific cases, especially when the ceiling is lower (as for single fork configuration) it can happen that a cupola light hits the bumper during manipulation with a specific angle.For this reason maquet sas recommends to secure the bumpers with screws as specified in the technical manual for every single fork configuration.To prevent any similar incident maquet sas recommends: ¿ to avoid collision.¿ to check the correct positioning of the cover after maintenance or cleaning.¿ to secure the bumpers with screws.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.The correction of # describe event or problem field deems required.This is based on the internal evaluation.#b5: previous describe event or problem: on 19th november, 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that cover's detachment occurred.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.Corrected describe event or problem: on 19th november, 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that bumper fallen down.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Event Description

On 19th november, 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that bumper fallen down.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

• Brand Name: HANAULUX 3000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10905144
• MDR Text Key: 219159428
• Report Number: 9710055-2020-00483
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARD567902999
• Device Catalogue Number: ARD567902999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1