MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

Catalog Number 8606500

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported there was a mixer and ventilator failure during a case.There no injury reported.

Manufacturer Narrative

The electronic log file was evaluated.A sporadic malfunction of a cpu board which controls the device-internal communication between user interface and gas mixer could be clearly identified as the root cause.Dräger knows a certain number of similar cases where a sporadic breakdown of device-internal communication occurred.This leads to a situation where ventilator and gas mixer enter a fail state simultaneously; the device is designed to switch to monitoring mode then and to alert the user to this condition by means of a corresponding alarm.Manual ventilation with emergency oxygen dosage remains possible, this includes application of anesthetic gas as well.The monitoring functionalities remain unaffected.The procedure how to establish the emergency gas supply is laid down in the ifu.In all comparable cases it was only possible to narrow down the root cause to the respective pcb cpu - the exact failure mechanism however could not be determined by in-depth analysis.The fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application periphery makes a general design issue rather unlikely.A reasonable explanation would be electrostatic discharge of the user during interaction with the device or any other kind of electromagnetic disturbance that exceeds the immunity barriers of the device.The primus was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

See initial report.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7536356
• MDR Text Key: 109256609
• Report Number: 9611500-2018-00147
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: 8606500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1