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

Model Number ARDPWD506004A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

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) 2021 getinge became aware of an issue with powerled surgical light.The housing of spring arm broke, leading to detachment of internal pin.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of d4 model # and catalog # fields deem required.This is based on the internal evaluation.Previous d4: model #ard267800350a.Catalog #ard267800350a.Corrected d4: model #ardpwd506004a.Catalog #ardpwd506004a.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with powerled surgical light.The housing of spring arm broke, leading to detachment of internal pin.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as pin should not be missing - and therefore it contributed to incident.There is no indication that at the time when the event occurred, the device was being used for patient treatment or diagnosis.The breakage has probably been caused by an important shock due to the spring arm release when it was in low position and without the light head.The direct consequence of this incident is the breakage of the covers of the spring arm.This incident is due to in improper use of the spring arm during an installation or maintenance procedure.

Event Description

Manufacturer reference number (b)(4).

• 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
• MDR Report Key: 11385194
• MDR Text Key: 233750954
• Report Number: 9710055-2021-00078
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

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 Operator: No Information
• Device Model Number: ARDPWD506004A
• Device Catalogue Number: ARDPWD506004A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/02/2021; 05/12/2021
• Supplement Dates FDA Received: 03/26/2021; 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1