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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 550 LIGHTS

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DRÄGERWERK AG & CO. KGAA POLARIS 550 LIGHTS Back to Search Results
Catalog Number G25066
Device Problem Device Fell (4014)
Patient Problem No Information (3190)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up/final report.
 
Event Description
It was reported that an incident occur with a medical light / camera assembly which allegedly fell on a patient in the operating theatre at the cardiac theatre. It appears the camera assembly attached to the light has been used as a handle forcefully or over time to position the light which has caused the camera to detach from the screws in the light housing. The base flange of the camera looks to be made of plastic from which the screws have pulled out. The patient had to be x-rayed to ensure parts that fell from the camera were not inside their body after the incident (small screws, etc. ). No further patient consequences reported.
 
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Brand NamePOLARIS 550
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 Key10288094
MDR Text Key199240817
Report Number9611500-2020-00243
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
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 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG25066
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2020 Patient Sequence Number: 1
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