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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.
 
Manufacturer Narrative
For the investigation the provided information, photos and technical reports were analyzed.A detailed technical information regarding the present malfunction scenario was already provided onsite by an involved dräger specialist.The affected device was not available for a detailed investigation.According to the technical report a fallen dräger surgical light sola 700 on an outsourced hospital employee during the post-surgery room cleaning process could be confirmed.No mechanical failures were identified at the junction of the dome with the spring arm, and while checking the affected operating room onsite, the items of the spring arm parts kit g94494 (lock and cover) were found.However, the locking screw that secures the lock protection cover (locking or securing sleeve) was not found.There were no structural or technical failure seen at the interior and exterior of the spring arm connection with the integral dome onsite.In the course of the investigation it can be concluded that due to the absence of the screw responsible for fixing the locking sleeve, during the cleaning process this part was moved upwards, exposing the locking segment that was released, causing the dome to yield.As the cover requires external action to move and is not located in a region where the equipment operates (region used to move the dome during surgery) the incident could not have occurred during a surgical procedure.This locking screw may have fallen off during other cleaning procedures during the last preventive which was held approximately one year before the incident.The light system connected to the spring arm cannot fall down spontaneously as due to the consistently vertical arrangement of the lower spring arm socket, it can be assumed that the spring arm locking sleeve located here will remain in its end position on the spring arm without manipulation or mechanical action from the outside, even if it is (incorrectly) not screwed on itself, due to the earth's gravitational pull, and thus prevents the locking element located under or behind the locking sleeve from falling out.A falling of light head can lead to a patient or user injury, in particular as reported in the present case.A disturbance of a surgical procedure is not known in this context.According to the instructions for use the arm and light system has to be checked regarding its operational readiness before each use.There is no apparent design or manufacturing error contributed to the described event.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
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 Name
SOLA 500/700
Type of Device
LIGHTS
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
1 Patient was 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 Health Professional
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
Patient Sequence Number1
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