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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 ARD568350933
Device Problems Crack (1135); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2021
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On 17th january, 2021 getinge became aware of an issue with powerled surgical light. As it was stated, the handle ring was broken. Photographic evidence shows that particles are missing. There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause 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 Key11228392
MDR Text Key228635882
Report Number9710055-2021-00024
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeUK
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 02/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberARD568350933
Device Catalogue NumberARD568350933
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 Received01/27/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/02/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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