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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL
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MAQUET SAS POWERLED II; LAMP, SURGICAL Back to Search Results
Model Number ARDPWT209011A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturing site.Other text : device not returned to manufacturer.
 
Event Description
On (b)(6) 2019 getinge became aware of an issue with surgical light ¿ powerled ii.As it was stated, down tube cap came loose and fell off into sterile field during case.There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.
 
Manufacturer Narrative
Getinge became aware of an issue with surgical light ¿ powerled ii.As it was stated, down tube cap came loose and fell off into sterile field during case.There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the down tube cap shouldn¿t be in a state in which it can detach, and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.It was established that the detachment of the down tube cap was caused by an improper fitting due to the protrusion of earth fixing head screw.It was probably mounted upside down during the installation.Moreover, it appeared that the protrusion of the earth fixing head screw restricted the fitting of the inner part of the cover in the suspension axle.The inner part of the cover was probably cut to avoid the contact with the protrusion of the head screw and then the cap wasn¿t able to be attached properly.Therefore, we conclude that the root cause of the issue is related to the installation process.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.We believe that our devices are performing correctly on the market.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name
POWERLED II
Type of Device
LAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key9457178
MDR Text Key179255218
Report Number9710055-2019-00361
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARDPWT209011A
Device Catalogue NumberARDPWT209011A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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