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

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 21st january, 2021 getinge became aware of an issue with prismatic surgical light.As it was stated, both lights turned off during procedure.There was no injury reported.We decided to report the event in abundance of caution as it may cause a delay in life-saving treatment.

Manufacturer Narrative

Getinge became aware of an issue with prismatic surgical light.As it was stated, both lights turned off during procedure.There was no injury reported.We decided to report the event in abundance of caution as it may cause a delay in lifesaving treatment.It was established that when the event occurred, the device did not meet its specification as it should not turn off and it contributed to the event.The provided information indicated that the device was being used for patient treatment when the event took place.During the investigation it was found that it is considered as single and isolated event.According to the information collected, it seems that the power supply of that the device was not involved, the power failure came from the hospitals' main power supply.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.We believe that remaining devices are performing correctly in the market.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: PRISMATIC
• 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: 11348729
• MDR Text Key: 232554143
• Report Number: 9710055-2021-00068
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1