MAUDE Adverse Event Report: MAQUET SAS HLX 3004/ HLX 3005; LAMP, SURGICAL

Model Number ARD567905999/ARD567904999

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 17th june, 2022 getinge became aware of an issue with one of surgical lights - hanaulux.It was stated the joint was broken.Based on the previous complaints with such description of the issue could be the detachment of connection between arms.We decided to report the issue in abundance of caution as detachment of connection between arms could lead to fall of the headlight into sterile field or during procedure and it may cause contamination or serious injury.

Manufacturer Narrative

The correction of d1 brand name and d4 catalog # deems required.This is based on the internal evaluation.Previous d1 brand name: hlx 3015.Corrected d1 brand name: hlx 3004/ hlx 3005.Previous d4 seral # (b)(6).Corrected d4 serial # (b)(6).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.

Event Description

Manufacturer reference number (b)(4).

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.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hlx.It was stated the joint was broken.Based on the previous complaints with such description of the issue it could lead to the detachment of connection between arms.We decided to report the issue in abundance of caution as detachment of connection between arms could lead to fall of the headlight into sterile field or during procedure and it may cause contamination or serious injury.According to the information provided by getinge technician, the affected device will be replaced by new volista surgical light.It was established that when the event occurred, the surgical light did not meet its specification due to broken joint in hlx surgical lights, which contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.As stated by the subject matter expert at manufacturing site, the rupture of the front pivot was caused by a tearing of the spring arm tube at the edge of the welding joint.The contributing factors correspond to excessive or repetitive mechanical stresses.The spring arm design changed, in 2006, by increasing the thickness of the tube.The field action msa/2017/002/iu was launched in september 2017 in order to replace the former acrobat 2000 spring arms, manufactured between 2004 and 2006, by the new spring arms including a tube thickness of 2,35 mm.The spring arm involved was and is to be replaced following the instruction of the service bulletin sb 36 and the field safety notice.However, as the defective part has been already scrapped, it was not possible to confirm if the related spring arm was addressed or not.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HLX 3004/ HLX 3005
• 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: 14885036
• MDR Text Key: 303707187
• Report Number: 9710055-2022-00252
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567905999/ARD567904999
• Device Catalogue Number: ARD567905999/ARD567904999
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Date Device Manufactured: 08/04/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1