Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; LIGHT, SURGICAL, CEILING MOUNTED
  • 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; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568370927
Device Problems Crack (1135); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2024
Event Type  malfunction  
Event Description
On 13th february, 2024 getinge became aware of an issue with one of surgical lights - powerled 700.During preventive maintenance it was found that switch of a lamp was defective.Photographic evidence indicated that keypad membrane detached from keypad and was damaged with possibility of missing particles, also the designated complaint unit employee found that paint on fork was damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
 
Manufacturer Narrative
The initial reporter was getinge technician.H3 other text : device not returned to manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERLED
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
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 Key18737997
MDR Text Key336761837
Report Number9710055-2024-00164
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568370927
Device Catalogue NumberARD568370927
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/13/2024
Initial Date FDA Received02/20/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/23/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-