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

Model Number HM56003602

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that part of spring arm's cover craced and detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights ¿ hanaulux 2003.The subject of the complaint is that part of spring arm's cover cracked and detached.There was no injury reported however, we decided to report the issue in abundance of caution 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 the cover cracked and detached and it contributed to the event.There is no information if upon the event occurrence, the device was or was not being used for patient treatment.The incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.

Event Description

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

Event Description

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

Manufacturer Narrative

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

• Brand Name: HANAULUX 2000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11076389
• MDR Text Key: 223730031
• Report Number: 9710055-2020-00524
• 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,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HM56003602
• Device Catalogue Number: HM56003602
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1