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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VARIOLUX; LIGHTS
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DRÄGERWERK AG & CO. KGAA VARIOLUX; LIGHTS Back to Search Results
Catalog Number MP00590
Device Problems Device Handling Problem (3265); Device Fell (4014)
Patient Problem Head Injury (1879)
Event Date 12/10/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.Investigation on-going.
 
Event Description
The user facility report stated: the examination light, which was attached to the standard rail, had to be held by a member of staff, as the light could no longer be fixed in the lowest joint.Another staff member wanted to take over and was standing directly behind the staff member as she wanted to move to the other side of the bed.The staff member had leaned the light fixture against the bed from behind to bridge the moment of takeover, where it was also fixed.The next moment, the light fell to the floor right next to the bed and almost hit the child or mother.One of the two employees was hit in the head.The lamp fell out of its fastening.The attachment to the standard rail was relatively far to the left of the bed.No injury was reported as a result of this incident.
 
Manufacturer Narrative
The investigation was carried out based on the communication with the user and the provided variolux.The variolux has three relevant attachment points.The first bracket is a locking screw that attaches the lamp to the standard mounting rail which does not affect positioning.The other two postures are knobs at the bottom and center of the holding arm to allow for up and down movement.The knob is based on friction to allow smooth adjustment.The locking screw was fully functional during the test, and when properly secured, the lamp would not dislodge from the rail.The two retaining screws on the holding arm could also be tightened so that the variolux holds its position even when the babyleo was shaken a lot.More force was required at the lower knob than at the knob in the middle of the arm.The holding force required at the lower knob is higher due to the design and does not represent a malfunction.When knobs were not sufficiently tightened during the test, the reported downward movement of the lamp could be reproduced.This downward movement is continuous and not jerky.The less the knob is tightened, the faster the movement.The movement is obvious as in this case also described by the user.However, this cannot cause the lamp to fall, since the independent locking screw must also be insufficiently tightened.Based on the analysis results, we conclude that user error was the cause of the event.Both the locking screw and the lower knob were not tightened correctly, causing the lamp to move downwards and fall down.The device was continued to be used by the user despite the identified positioning problems and was not replaced.Based on the investigation results, the case was rated as not reportable.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
The user facility report stated: the examination light, which was attached to the standard rail, had to be held by a member of staff, as the light could no longer be fixed in the lowest joint.Another staff member wanted to take over and was standing directly behind the staff member as she wanted to move to the other side of the bed.The staff member had leaned the light fixture against the bed from behind to bridge the moment of takeover, where it was also fixed.The next moment, the light fell to the floor right next to the bed and almost hit the child or mother.One of the two employees was hit in the head.The lamp fell out of its fastening.The attachment to the standard rail was relatively far to the left of the bed.No injury was reported as a result of this incident.
 
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Brand Name
VARIOLUX
Type of Device
LIGHTS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key16041850
MDR Text Key306087428
Report Number9611500-2022-00358
Device Sequence Number1
Product Code KZF
Combination Product (y/n)N
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
Report Date 03/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMP00590
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
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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