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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 2000 PLUS VENTILATORS, TRANSPORT

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DRÄGERWERK AG & CO. KGAA OXYLOG 2000 PLUS VENTILATORS, TRANSPORT Back to Search Results
Catalog Number 5708080
Device Problems Fire (1245); Smoking (1585)
Patient Problems Bruise/Contusion (1754); No Consequences Or Impact To Patient (2199)
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 routine maintenance of an oxylog 2000 plus, the unit started to emit white smoke from the back while being connected to a test lung. Afterwards, there was a high thermal event. The technician disconnected the unit from the hospital oxygen supply and put off the fire. He ended up with some minor bruises. No further consequences were reported.

 
Manufacturer Narrative

The investigation was based on the photos of the device after the event and the response to further questions. The affected device was requested, but has not been provided. Based on the photos and the description of event it could be concluded that likely an ignition in one of the battery cells of the lithium-ion battery was the cause for the high thermal event. It was further reported by the user that the battery was handled properly and not physically damaged. However, according to the instructions for use the battery was due for replace in (b)(6) 2019. As the material was not available for further analyses, a definite root cause could not be determined. In general, the lithium-ion battery for the oxylog incorporates state of the art technology to reduce possible risks and impact of a potential ignition. It has been developed to comply with the requirements of the international standard iec 62133 and passed all the required tests. The internal electronics and the housing of the device are made of materials which act as flame retardant. No similar case related to the same cause has been reported in the last 18 years. Therefore, this is considered an isolated case.

 
Event Description

Please refer to the initial-report.

 
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Brand NameOXYLOG 2000 PLUS
Type of DeviceVENTILATORS, TRANSPORT
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8645227
MDR Text Key146274445
Report Number9611500-2019-00157
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeIR
PMA/PMN NumberK082600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device Catalogue Number5708080
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/31/2009
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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