MAUDE Adverse Event Report: MAQUET SAS HLX 2005; LAMP, SURGICAL

Model Number HM58000502

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020, getinge became aware of an issue with hanaulux 2005 surgical light.As it was stated, the pillar was broken and no particles were missing.This problem represents non-reportable event, however, the paint, and label was chipping from the light head.There was no injury reported.We decided to report the issue in abundance of caution, as any particles falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Getinge became aware of an issue with hanaulux 2005 surgical light.As it was stated, the pillar was broken and no particles were missing.This problem represents non-reportable event, however, the paint and label was chipping from the light head.There was no injury reported.We decided to report the issue in abundance of caution, as any particles 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 (paint and label peeling) and it contributed to the event.Upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.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.Given the circumstances and the fact that there is no apparent trend in complaints 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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: HLX 2005
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10600618
• MDR Text Key: 208989294
• Report Number: 9710055-2020-00375
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HM58000502
• Device Catalogue Number: HM58000502
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1