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

Model Number ARD568411010C

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the paint was peeling and the particles of paint has flaked into open cavity of the chest of a patient during procedure.There is no indication of the injury of the patient.Paint flake has been removed from patient.However, we decided to report the issue as serious injury due to possible contamination of the chest cavity of the patient which could lead to local or system infection.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

The correction of d4 catalog # field deem required.This is based on the internal evaluation.Previous d4 catalog #: ard568411010c.Corrected d4 catalog#: 568350931/568370930/568370930.Getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the paint was peeling and the particles of paint has flaked into open cavity of the chest of a patient during procedure.There is no indication of the injury of the patient.Paint flake has been removed from patient.However, we decided to report the issue as serious injury due to possible contamination of the chest cavity of the patient which could lead to local or system infection.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to paint peeling from the forks, which could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does indicate that upon the event occurrence, the device was being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of paint peeling on powerled and hled surgical lights, there is one event which led to the serious injury.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the paint chipping is moderate.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 (powerled¿s ifu 01581 rev.9, page 27) 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 (powerled¿s ifu 01581 rev.9, page 27).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 the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

Manufacturer Narrative

The correction of date received by mfg in section g: previously entered in error as 11/21/2022 where as the correct date is 1/17/2024.

• Brand Name: POWERLED
• 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: 15769692
• MDR Text Key: 303394740
• Report Number: 3013876692-2022-00069
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568411010C
• Device Catalogue Number: ARD568350931/ARD568370930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2024
• Distributor Facility Aware Date: 01/17/2024
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2024
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other