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

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 600 LIGHTS

  • 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
 

DRÄGERWERK AG & CO. KGAA POLARIS 600 LIGHTS Back to Search Results
Catalog Number G16730
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported: "the newly installed operating room light system with two lights from dräger, type: polaris 600, detached with the entire supporting structure from the column construction mounted on the ceiling in (b)(6) 2020. The two lights with the associated support arms were only attached to their cabling, which at the same time prevented the entire construction from falling onto the operating room floor. The entire substructure of the or lights completely detached from the ceiling-mounted support tube/column and slid down. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOLARIS 600
Type of DeviceLIGHTS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11561381
MDR Text Key243743280
Report Number9611500-2021-00121
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
PMA/PMN Number
-
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG16730
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-