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

Model Number	ARD568420710A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was (b)(6) from the maintenance department of the hospital.The unique identifier (udi) # information is not available since the device was manufactured before september 2016.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the fork arm was coming apart, there was a mechanical gap between two light forks.According to the information provided by getinge technician no one was harmed.There was no injury reported, however, we decided to report the issue in abundance of caution as fork and lighthead detachment during procedure may cause serious injury.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 catalog#, d4 unique identifier (udi)# fields deems required.This is based on the internal evaluation.Previous d1 brand name: powerled 700, corrected d1 brand name: powerled tm, previous d4 catalog#: ard568420710a, corrected d4 catalog#: none, previous d4 unique identifier (udi): n/a, corrected d4 unique identifier (udi)#: (b)(4).Getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the fork arm was coming apart, there was a mechanical gap between two light forks.According to the information provided by getinge technician no one was harmed.There was no injury reported, however, we decided to report the issue in abundance of caution as fork and lighthead detachment during procedure may cause serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Root cause analysis was performed by subject matter experts at the manufacturers.As they stated, the root cause of this incident is due to the loosening of one of the screws.The reason of these loosened screws remains unknown because it is glued with loctite 222 during assembly in factory.Once the manipulation of the lights is detected as abnormal by the user, a repair must be done as soon as possible.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: POWERLED TM
• Common Device Name: 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: 19970219
• Report Number: 9710055-2024-00468
• Device Sequence Number: 15649552
• Product Code: FSY
• UDI-Device Identifier: 03700712403089
• UDI-Public: (01)03700712403089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARD568420710A
• Device Catalogue Number: ARD568420710A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown