MAUDE Adverse Event Report: MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568331999

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Protective Measures Problem (3015)

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

Event Date 12/12/2022

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)2022.Getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the cover on the spring arm was un-snapped.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination on serious injury.

Event Description

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

Manufacturer Narrative

Technician informed that the side cover was re-attached properly and verify.It was established that when the event occurred, the surgical light did not meet its specification due to cover on the spring arm was un-snapped, which contributed to the event.Provided information indicates that when the event occurred the device was not being used for patient treatment.The review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the missing covers from a spring arm is moderate.According to the subject matter expert at the manufacturing site, the incident is due to inappropriate use.To prevent such an issue from reoccurring, the manufacturer¿s recommendation is to follow the instructions from the operating manual concerning arm pre-positioning prior to use (ifu 015181 en 09 pages 27-29).Additionally, users are requested to pay attention to cracks in plastic parts (ifu 015181 en 09 pages 20-22).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.

• Brand Name: POWERLED 300
• 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: 16023871
• MDR Text Key: 306100782
• Report Number: 9710055-2022-00542
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: ARD568331999
• Device Catalogue Number: ARD568331999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1