MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000; VENTILATORS, TRANSPORT

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Electric Shock (2554)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was sent in to the dräger workshop in (b)(4) and tested against complete test specification and passed.The reported event and screen shots of the device log have been analyzed by the manufacturer.It can be excluded that the electrical shock with high voltage was created by the oxylog.The device was not connected to mains supply and ran on 12 v battery.Reportedly the user touched the device with two fingers at the top when the discharge occurred.This is near the metallic claw which is used to couple the oxylog on the front of the bed.Therefore it can be assumed that an electrostatic discharge occurred which ran from the user via the claw and the bed to the ground.A check of weather data shows that around (b)(6) 2016 the weather in adelaide was hot with a drop of relative humidity to 33 % r.H.This is a condition under which people can get electrically charged if they don¿t use antistatic shoes and clothes.The oxylog 3000 is designed and tested to withstand electrostatic discharge up to 15.000 v as required in the relevant international standard.But we learned that in rare cases this value can be exceeded.The oxylog 3000 behaved as specified for this extreme condition, stopped ventilation to prevent from undefined conditions and generated alarm.In this situation the patient system is automatically opened to atmosphere to make spontaneous breathing possible.Analysis of our vigilance data of the last three years showed that the reported event is an isolated case.

Event Description

It was reported that a user received a heavy electrical shock when he touched the transport-ventilator during an intra-hospital patient transport and that the transport-ventilator generated alarm and stopped ventilation.There was no injury reported.

• Brand Name: OXYLOG 3000
• Type of Device: VENTILATORS, TRANSPORT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 5519321
• MDR Text Key: 41313428
• Report Number: 9611500-2016-00071
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2005
• 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