MAUDE Adverse Event Report: MAQUET SAS BLUE 30; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD569050999

Device Problems Melted (1385); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

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)2023 getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover was melted which resulted in missing particles. there was no injury reported, however, we decided to report the issue in abundance of caution as overheating resulting in particles falling off into sterile field or during procedure may cause serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.There was no injury reported, however, we decided to report the issue in abundance of caution.It was established that when the event occurred, the device did not meet its specification, due to an out-of-spec light source being used, leading to the damaged cover which contributed to event.Despite our best attempts it was not established if upon the time when the event occurred the device was, or was not, being used for the patient treatment.During our investigation it was found via the on-site inspection by the getinge technician, that the customer used bulbs that were too strong and that this caused the damage as shown in the pictures.The root cause was further analyzed by a subject matter expert at the manufacturing site.They found that, according to the information that could be obtained, only a strong over heating could have led to such a damage.And that a bulb too strong in power led to over heating and damaged the light head.This is considered to be the root cause of this incident - which is related to misuse.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover was melted which resulted in missing particles. there was no injury reported, however, we decided to report the issue in abundance of caution as overheating resulting in particles falling off into sterile field or during procedure may cause serious injury.Corrected b5 describe event or problem: on 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.There was no injury reported, however, we decided to report the issue in abundance of caution.

Event Description

On 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.There was no injury reported, however, we decided to report the issue in abundance of caution.

Event Description

On 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blue 30.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.On 1st may, 2023, further photographic evidence showing the paint peeling from the fork was provided to the record.There was no injury reported, however, we decided to report the issue in abundance of caution.

Manufacturer Narrative

Previous b5 describe event or problem: on 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.There was no injury reported, however, we decided to report the issue in abundance of caution.Corrected b5 describe event or problem: on 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blue 30.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.On 1st may, 2023, further photographic evidence showing the paint peeling from the fork was provided to the record.There was no injury reported, however, we decided to report the issue in abundance of caution.Previous d1 brand name: blueline.Corrected d1 brand name: blue 30.Previous e1 event site name: hermed med-tech corrected e1 event site name: seespital horgen previous h10 additional manufacturer narrative: getinge became aware of an issue with one of our surgical lights ¿ blueline.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.There was no injury reported, however, we decided to report the issue in abundance of caution.It was established that when the event occurred, the device did not meet its specification, due to an out-of-spec light source being used, leading to the damaged cover which contributed to event.Despite our best attempts it was not established if upon the time when the event occurred the device was, or was not, being used for the patient treatment.During our investigation it was found via the on-site inspection by the getinge technician, that the customer used bulbs that were too strong and that this caused the damage as shown in the pictures.The root cause was further analyzed by a subject matter expert at the manufacturing site.They found that, according to the information that could be obtained, only a strong over heating could have led to such a damage.And that a bulb too strong in power led to over heating and damaged the light head.This is considered to be the root cause of this incident - which is related to misuse.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Corrected h10 additional manufacturer narrative: on 30th january 2023 getinge became aware of an issue with one of our surgical lights ¿ blue 30.According to the photographic evidence, the headlight's cover has melted to a degree where it became severely deformed and the side came loose.On 1st may, 2023, further photographic evidence showing the paint peeling from the fork was provided to the record.There was no injury reported, however, we decided to report the issue in abundance of caution.It was established that when the event occurred, the device did not meet its specification, due to mechanically damaged cover and paint peeling which contributed to event.It was not established if upon the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenarios have never led, to date, to serious injury or worse.A root casue regarding the melted cover was further analyzed by the subject matter expert at manufacturing site.As stated, according to the picture provided, only a strong over heating could have led to such a damage.Furthermore, information provided by getinge technician indicates that customer used bulbs that were too strong and that everything was fried.A bulb too strong in power led to over heating and damaged the light head.This the root cause of this incident which is related to misuse.A root cause analysis for paint peeling problem was performed by subject matter experts and concluded that 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 (ifu nu 0136102 en ed2b, page 12) 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 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 paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issues we also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.

• Brand Name: BLUE 30
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 16311241
• MDR Text Key: 308943095
• Report Number: 9710055-2023-00095
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569050999
• Device Catalogue Number: ARD569050999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 04/05/2023; 05/01/2023
• Supplement Dates FDA Received: 04/18/2023; 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1