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

Model Number HM56067740

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On (b)(6), 2021 getinge became aware of an issue with one of surgical lights - hlx 3000.At it was stated the lenses of light were cracked and the particles were missing.We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The new obtained information is manufacturing date: aug-1993.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.

Manufacturer Narrative

The correction of b5 describe even or problem, d1 brand name and d4 version of model # deems required.This is based on the internal evaluation.Previous b5 describe even or problem: on 16th november, 2021 getinge became aware of an issue with one of surgical lights - hlx 3000.At it was stated the lenses of light were cracked and the particles were missing.We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe even or problem: on 16th november, 2021 getinge became aware of an issue with one of surgical lights - hlx 2004.At it was stated the lenses of light were cracked and the particles were missing.We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.Previous d1 brand name: hlx 3000.Corrected d1 brand name: hlx 2004.Previous d4 version of model #: hlx 3000.Corrected d4 version of model #: hm56067740.Getinge became aware of an issue with one of surgical lights - hlx 2004.At it was stated the lenses of the surgical light were cracked and the particles were missing.We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification due to the cracked lenses, which contributed to the event.Provided information indicates that upon the issue detection, the device was not being used for patient treatment.Unfortunately, maquet did not receive enough information to conduct the technical investigation.Based on the review by the subject matter expert at manufacturer, it is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.However, as stated by subject matter expert at manufacturer¿s, the most probable causes in this case are collisions.What could have also contributed to the problem is the age of the affected device.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 16th november, 2021 getinge became aware of an issue with one of surgical lights - hlx 2004.At it was stated the lenses of light were cracked and the particles were missing.We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: HLX 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: 12974066
• MDR Text Key: 282032511
• Report Number: 9710055-2021-00371
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HM56067740
• Device Catalogue Number: HM56067740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1