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

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was performed based on analysis of the electronic log file.A sporadic malfunction of a cpu board which controls the device-internal communication between user interface and vgc (ventilation and gas controller) was identified to be root cause of the reported failure.This internal communication failure leads to a shutdown of the ventilator and gas mixer simultaneously.In this situation, the device automatically switches to monitoring mode while alarming the user to this condition by means of a corresponding alarm.Manual ventilation with emergency oxygen dosage remains possible including the application of anesthetic gas as well.The monitoring functionality remains unaffected.The procedure how to establish the emergency gas supply is described in the instructions for use.Dräger finally concludes, that the device has reacted according to its safety concept and has performed an emergency shutdown of the affected components accompanied by the respective alarms.After the shutdown the user rebooted the device, performed a successful power-on self-test and continued the ventilation without further issues.Similar cases are known ¿ however, the exact failure mechanism could not be determined during in-depth analysis.It was only possible to narrow down the root cause to the respective pcb, which was already replaced as a precautionary measure.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 apollo was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that a gas mixer failure has occurred during use.The operators reportedly power-cycled the device, performed the self-test which was passed and have further used the device w/o problems.Investigation at dräger revealed that indeed a ventilator failure occurred whereby the case was re-assessed as reportable.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12329683
• MDR Text Key: 271489316
• Report Number: 9611500-2021-00348
• Device Sequence Number: 1
• Product Code: BSZ
• 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
• Report Date: 08/17/2021

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
• Was Device Available for Evaluation?: No
• Device Age: 16 YR
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2005
• 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