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

Model Number HLED

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/25/2021

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), 2021 getinge became aware of an issue with one of surgical lights - hled.The spring arm cover fell off.It was decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination or injury.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hled.The spring arm cover fell off.It was decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination or injury.The defective spring arm cover was replaced and the device was returned to service.It was established that when the event occurred, the surgical light did not meet its specification due to the spring arm cover falling off, which contributed to the event.Provided information do not indicate if upon the event occurrence the device was being used for patient treatment.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.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of spring arm cover falling off the device occurrence is low.According to the subject matter expert at the manufacturer, the incident is due to an inappropriate use.To prevent such an issue from reoccurring, manufacturer¿s recommendation is to follow the instructions from operating manual concerning arm pre-positioning prior to use.Additionally, users are requested to pay attention to cracks in plastic parts.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: HLED
• 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: 13116560
• MDR Text Key: 282957517
• Report Number: 9710055-2021-00386
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/03/2022

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 Model Number: HLED
• Device Catalogue Number: ARD568330953
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/25/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1