MAUDE Adverse Event Report: GETINGE / MAQUET S.A.S. GETINGE POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number POWERLED

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Description

Pwd500 seal kit (p/n ard368324555) on getinge or lights always breaks apart at the joint every 5 months and has to be repurchased/reinstalled.It falls apart during cases in the operating room and can cause pt injury.I've notified the mfr but no response for over a year.Fda safety report id# (b)(4).

• Brand Name: GETINGE POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): GETINGE / MAQUET S.A.S.
• MDR Report Key: 15391316
• MDR Text Key: 299770880
• Report Number: MW5111947
• 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: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/06/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: POWERLED
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1