MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2004; LAMP, SURGICAL

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ hanaulux 2003.As it was stated, the headlight fell on ground.No injury has been reported due to described issue, however, we decided to report this case based on potential as any part falling down could lead to serious injury.

Event Description

On (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ hanaulux 2004.As it was stated, the locking ring loosened and went missing, resulting in detachment of the examination light (headlight, spring arm and extension arm).No injury has been reported due to described issue, however, we decided to report this case based on potential as any part falling down could lead to serious injury.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of d1 brand name and b5 describe event or problem fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 30th of march 202, getinge became aware of an issue with one of our surgical lights ¿ hanaulux 2003.As it was stated, the headlight fell on ground.No injury has been reported due to described issue, however, we decided to report this case based on potential as any part falling down could lead to serious injury.Corrected b5 describe event or problem: on 30th of march 2022, getinge became aware of an issue with one of our surgical lights ¿ hanaulux 2004.As it was stated, the locking ring loosened and went missing, resulting in detachment of the examination light (headlight, spring arm and extension arm).No injury has been reported due to described issue, however, we decided to report this case based on potential as any part falling down could lead to serious injury.Previous d1 brand name: hanaulux 2003.Corrected d1 brand name: hanaulux 2004.

• Brand Name: HANAULUX 2004
• 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: 13974946
• MDR Text Key: 288370558
• Report Number: 9710055-2022-00101
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1