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U.S. Department of Health and Human Services

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

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MAQUET SAS POWERLED LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568370906
Device Problems Crack (1135); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided upon results of investigation.

 
Event Description

On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - powerled. As it was stated during maintenance of the device paint peeling on fork and light handle was found. Moreover cracked cover of the locking segment was also found. Photographic evidence of the issue was in line with alleged situation. No information about any injury has been provided however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.

 
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Brand NamePOWERLED
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key11618648
MDR Text Key243913159
Report Number9710055-2021-00122
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberARD568370906
Device Catalogue NumberARD568370906
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/11/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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