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

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.

• Brand Name: OXYLOG 2000 PLUS
• Type of Device: VENTILATORS, 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 Key: 8645227
• MDR Text Key: 146274445
• Report Number: 9611500-2019-00157
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K082600
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 5708080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1