• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED II LAMP, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS POWERLED II LAMP, SURGICAL Back to Search Results
Device Problem Unintended Collision (1429)
Patient Problem Stroke/CVA (1770)
Event Type  Injury  
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 powerled ii surgical light. As it was stated, spring arm of surgical light collided and wedged with another equipment. It caused delay of active stroke case by 15 minutes. The patient survived, however the total impact is unknown at this time. We decided to report the issue as such situation lead to serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12951448
MDR Text Key281843236
Report Number9710055-2021-00370
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/07/2021 Patient Sequence Number: 1
-
-