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

Model Number HM56067730

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/31/2021

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 - hanaulux 2000.The safety ring on spring arm was missing.There was no injury reported however we decided to report the issue based on the potential as lack of safety ring may leads to detachment of light head, moreover, fall of any parts into sterile field may leads to contamination.

Event Description

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

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of d4 model# and catalog# fields deems required.This is based on the internal evaluation.Previous d4.Model# hm56067742.Catalog# hm56067742.Corrected d4.Model# hm56067730.Catalog# hm56067730.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hanaulux 2000.The safety sleeve on spring arm was missing what was confirmed by photography evidence.There was no injury reported however we decided to report the issue based on the potential as lack of safety sleeve may lead to detachment of light head, moreover, fall of any parts into sterile field may lead to contamination or injury.It was established that when the event occurred, the surgical light did not meet its specification as the safety sleeve was missing and it contributed to event.The operating theatre was under overhaul when event was reported so when the event occurred the device was not being used for the patient treatment.It was confirmed by technician that device was repair and put back into service.It was found that the possible root cause of the missing safety sleeve is a collision.The safety sleeve involved was not returned for evaluation.The absence of the safety sleeve can enable the removal of the safety segment, leading to the fall of the light head.A new safety sleeve ref hm56051827, available as spare parts, must be installed in order to avoid any incident.To prevent any safety issue the user manual ¿hlx 2000 nu 56351039 e, 8.1 inspection by the operator, page 20¿ indicates to check the plastic parts every six months.Therefore, the root cause of the issue is user related.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

Event Description

Manufacturer reference number (b)(4).

• 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: 11964135
• MDR Text Key: 255069990
• Report Number: 9710055-2021-00215
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HM56067730
• Device Catalogue Number: HM56067730
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1