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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL
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MAQUET SAS LUCEA 50; LAMP, SURGICAL Back to Search Results
Model Number ARDLCA309005A
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided upon results of investigation.Device not returned to manufacturer.
 
Event Description
On 29th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The purpose of this submission is solely to provide a correction of describe event or problem section this is based on the result of an additional information provided by sales and service unit.Previous describe event or problem: on 29th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.Corrected describe event or problem: on 6th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.
 
Event Description
On 6th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.Manufacturer reference number (b)(4).
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
Getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported, however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor 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 recommendations would have been followed the incident could have been avoided.
 
Event Description
On 29th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.Manufacturer reference number (b)(4).
 
Manufacturer Narrative
The purpose of this submission is solely to provide a correction of describe event or problem section.This is based on the result of an additional information provided by sales and service unit.#b5: previous describe event or problem: on 6th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.Corrected describe event or problem: on 29th of october 2020 getinge became aware if an issue related to one of our device - lucea 50.As it was stated, during the device inspection paint chipping from a fork was discovered.No information about patient involvement was reported however we decided to report this case in abundance of caution and based on potential as any paint particles falling into sterile field might be a source of contamination.
 
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Brand Name
LUCEA 50
Type of Device
LAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key10842669
MDR Text Key216342664
Report Number9710055-2020-00476
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARDLCA309005A
Device Catalogue NumberARDLCA309005A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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