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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 ARD568370900
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2020
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided upon results of investigation. Device not returned to manufacturer.

 
Event Description

On 28th of august, 2020 getinge became aware of an issue with one of our surgical light - powerled. As it was stated boom and light cover has missing particles or was held with zip tie. No information about any injury has been provided, however we decided to report this case in abundance of caution as any parts falling from the device could 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 Key10801068
MDR Text Key215367568
Report Number9710055-2020-00465
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberARD568370900
Device Catalogue NumberARD568370900
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 Received02/25/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/07/2010
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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