• 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 ARD568320905
Device Problems Corroded (1131); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
On 7th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the light head not turning smoothly.Designated complaint unit employee confirmed based on photographic evidence the corrosion has built up on the spring arm and elements of surface peeled off, and also that label was chipping off.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Event site name: (b)(6).Contact person name: (b)(6).Event site telephone: (b)(6).Initial reporter was biomed.Additional information will be provided following the conclusion of the investigation.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 Key18417384
MDR Text Key331590972
Report Number9710055-2023-00988
Device Sequence Number1
Product Code FSY
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 Biomedical Engineer
Type of Report Initial
Report Date 12/29/2023
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 Operator Health Professional
Device Model NumberARD568320905
Device Catalogue NumberARD568320905
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2023
Initial Date FDA Received12/29/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/15/2010
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-