MAUDE Adverse Event Report: MAQUET SAS HLX 2000; LAMP, SURGICAL

Model Number HM56003602

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.

Event Description

On 12th february, 2019 getinge became aware of an issue with one of surgical lights- hanaulux 2000.As it was stated, part of the ceiling cover fell off during surgery.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure may lead to contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights- hanaulux 2000.As it was stated, part of the ceiling cover fell off during surgery.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as piece of cover fell off and in this way device contributed to event.The device was being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Using to the information collected, the particular piece involved in the event was not identified, the ceiling cover was established to have been used in a damaged state, fixed by an adhesive tape.It was observed several plastic fixing tabs were found broken, and it is considered by subject matter experts at the manufacturing site that this condition probably led to the drop of a part or piece from the ceiling.The condition of the ceiling cover can be inspected by visual inspection.To prevent any safety issue the operating instructions 56351039/e mentions that hanaulux products are to be inspected by the operator every six months.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HLX 2000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10412460
• MDR Text Key: 203117069
• Report Number: 9710055-2020-00310
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HM56003602
• Device Catalogue Number: HM56003602
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1