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

Model Number ARD569422513A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our surgical light ¿ powerled.The customer alleged about light module which was intermittently staying on.Photographic evidence provided for this issue also reveal a layer of keypad that was peeling off.No information about any injury has been provided however we decided to report this case in abundance of caution as any parts peeling from the device could be a source of contamination.(b)(4).

Event Description

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

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light ¿ powerled.The customer alleged about light module, which was intermittently staying on.Photographic evidence provided for this issue also reveal a layer of keypad that was peeling off.No information about any injury has been provided however, we decided to report this case in abundance of caution as any parts peeling from the device could be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification as the keypad tape should not peel off and it contributed to incident.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.The keypad peeling off is a normal wear at this location.In the chapter daily inspections before use, the user manual mentions to check that the keypad is in good condition.As soon as a default is noticed on the keypad tape, its replacement must be performed.The tape is available as spare part.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances we 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).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 10612807
• MDR Text Key: 209386064
• Report Number: 9710055-2020-00396
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569422513A
• Device Catalogue Number: ARD569422513A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1