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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SOLA 500/700 LIGHTS

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DRÄGERWERK AG & CO. KGAA SOLA 500/700 LIGHTS Back to Search Results
Catalog Number G93777
Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem Pain (1994)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that during a cleaning and disinfection procedure, after a surgery, a surgical light sola 700 , fell on the arm of a hospital employer. She was feeling pain in her arm but hasn't had a serious injury.
 
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Brand NameSOLA 500/700
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 Key11601038
MDR Text Key244635461
Report Number9611500-2021-00140
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
PMA/PMN Number
K010724
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,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG93777
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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