MAUDE Adverse Event Report: MAQUET SAS HLED 70; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568521511C

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter was the department of maintenance.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 21st november, 2023 getinge became aware of an issue with one of surgical lights - hled 70.It was stated the camera was ripped from the headlight.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 21st november, 2023 getinge became aware of an issue with one of surgical lights - hled.It was stated the camera (osd zoom camera pal) was ripped from the headlight.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that this issue was caused by the customer (maintenance personnel), during the preventive maintenance.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing parts or particles during daily use, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The correction of b5 describe event and problem, d4 catalog #, h4 manufacture date and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 21st november, 2023 getinge became aware of an issue with one of surgical lights - hled 70.It was stated the camera was ripped from the headlight.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 21st november, 2023 getinge became aware of an issue with one of surgical lights - hled.It was stated the camera (osd zoom camera pal) was ripped from the headlight.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that this issue was caused by the customer (maintenance personnel), during the preventive maintenance.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing parts or particles during daily use, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous d4 catalog #: ard568521511c corrected d4 catalog #: ard567702909 previous h4 manufacture date: 2010-10-20 corrected h4 manufacture date: 2010-10-18 previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component 2907 corrected h6 medical device ¿ problem code: no apparent adverse event 3189 initially provided information was pointing to the camera which was ripped from the headlight.The issue is considered as safety related as any parts or particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the issue was caused by the customer (maintenance personel), during the preventive maintenance.It was determined that the issue investigated herein is not safety and risk related as there was no indication of missing parts or particles during daily use.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred, the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: HLED 70
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 18280834
• MDR Text Key: 329898062
• Report Number: 9710055-2023-00940
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ARD568521511C
• Device Catalogue Number: ARD567702909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1