• 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
Model Number ARDPWT229055A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 20th march, 2021 getinge became aware of an issue with powerled ii surgical light. As it was stated, installers of the equipment notched the rubber cap to fit the cap over the grounding screw. Over time, the grounding screw rubbed against the notch on the cap knocking it off onto the floor during a procedure with the patient on the table. There was no injury reported, however, we decided to report the issue based on the potential as it could lead to contamination of sterile field.
 
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 Key11551185
MDR Text Key243129531
Report Number9710055-2021-00107
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,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARDPWT229055A
Device Catalogue NumberARDPWT229055A
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 Received05/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

-
-