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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.
 
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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 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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
0 Patients were 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
Device Model NumberARDPWT209011A
Device Catalogue NumberARDPWT209011A
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 Received04/30/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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