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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 ARD569202915
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On 11th august, 2020 getinge became aware of an issue with one of surgical lights - powerled ii. As it was stated, caps and screws on spring arm were loose. There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.
 
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Brand NamePOWERLED II
Type of DeviceLAMP, SURGICAL
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 Key10422774
MDR Text Key203476322
Report Number9710055-2020-00328
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD569202915
Device Catalogue NumberARD569202915
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 Received12/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/26/2019
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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