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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000PLUS; VENTILATORS, TRANSPORT
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DRÄGERWERK AG & CO. KGAA OXYLOG 3000PLUS; VENTILATORS, TRANSPORT Back to Search Results
Catalog Number 5704831
Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
It has been reported that a used oxylog 3000plus device burned while connected to the line voltage and central o2 supply during the event.It appears that an initial flame occurred from the disposable breathing circuit connected to the device.No staff, nor patient health consequences have been reported.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Manufacturer Narrative
The investigation was based on the reported event, email correspondence and photo of the affected oxylog 3000 plus s/n.(b)(6).Later, the device was provided to the manufacturer for inspection.According to the investigation results, the housing shows severe heat / fire damages.However, based on the results of the examination, the source of the heat is unclear, but it is obvious that the oxylog cannot be the cause of the damage.The interior of the unit, particularly the pneumatics, shows no damage or evidence of heat or flame.The battery is also completely undamaged, as are the circuit boards, these show no signs of heat generation, only the area where the smoke entered the housing through the holes is stained black.Nor could the flame have been caused from the breathing tube system as reported, because the disposable breathing tube system with its very thin wall thickness could never carry the heat for such a long time as was necessary to cause the damage.Based on the damage to the side and rear of the equipment, it can be assumed that an external heat source must have been the cause of the fire, possibly caused by a gas flame or similar.These areas must have been exposed to tremendous heat for at least several minutes to cause this damage.In addition, there must have been some sort of "air flow" as molten particles/droplets of molten plastic were blown far inside the enclosure (see blue droplets on the pneumatic cover and orange splatter on the valve wires inside the pneumatic.No health consequences have been reported on users or patients.In case that the device is destroyed by a fire nearby it cannot be used any more and must be replaced.The event was classified as non-reportable according to the european meddev 2.12 rev.8 and the medical devices regulation (mdr (b)(4)), as no evidence of device malfunction or evidence of cause as a fire was detected from the device.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
 
Event Description
It has been reported that a used oxylog 3000plus device burned while connected to the line voltage and central o2 supply during the event.It appears that an initial flame occurred from the disposable breathing circuit connected to the device.No staff, nor patient health consequences have been reported.
 
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Brand Name
OXYLOG 3000PLUS
Type of Device
VENTILATORS, TRANSPORT
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
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key16459235
MDR Text Key310416173
Report Number9611500-2023-00077
Device Sequence Number1
Product Code CBK
UDI-Device Identifier04048675249221
UDI-Public(01)04048675249221(11)200220(93)5704811-22
Combination Product (y/n)N
PMA/PMN Number
K103625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5704831
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
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