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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 ARD569201917
Device Problem Device Handling Problem (3265)
Patient Problem Skin Tears (2516)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with one of surgical lights - powerled ii. As it was stated, when the nurse raised the monitor arm vertically her hand was placed under the dust cover that covers the connection of the spring arm and the monitor holder, the hand was pinched between the metal dust cover and the spring arm cover, in result the thumb has been cut. Medical intervention was not required, the device involved in the event was inspected and it was confirmed there was no fault found. We decided to report the issue in abundance of caution as pinch of hand may lead to serious injury.
 
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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 Key12195302
MDR Text Key262439558
Report Number9710055-2021-00248
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
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 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD569201917
Device Catalogue NumberARD569201917
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 Received08/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
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