MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG 8000; VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC

Catalog Number 8409200

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in the follow up-report.

Event Description

It was reported that a neo flow sensor burned when the user wanted to replace it.The circuit was removed from the patient but was still connected to device.The o2 concentration was 100%.The user took the circuit away from the patient but the skin of the patient got exposed to heat.The fire stopped when the device was switched off.The patient deceased due to the general bad health condition.The user did not attribute the passing of the patient to the device.

Manufacturer Narrative

It is very likely that through the handling of the flow sensor some particles of the deposits came in contact with the wires of the flow sensor.We assume that the contact of these particles with the wires of the flow sensor in combination with flammable residues in the flow sensor (e.G.From user handling/reprocessing.) was the reason for the ignition of the material during use.There is no indication of a device malfunction.Due to the operation principle of the flowsensor the wires of the flow sensor are operated at elevated temperatures.For calibration and necessary cleaning the wires are further heated up, but this is only performed without patient connected.The ifu of the babylog and in the ifu of the neo flow sensor contain several hints how to handle the flow sensor correctly to avoid ignition.The measuring principle of this neonatal sensor is used since 25 years meanwhile without problems when following the instructions for use.

Event Description

Please refer to the initial-report.

• Brand Name: BABYLOG 8000
• Type of Device: VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC
• 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: 6596463
• MDR Text Key: 76126609
• Report Number: 9611500-2017-00166
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K974176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8409200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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
• Patient Outcome(s): Life Threatening