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

Catalog Number 8605310

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

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 the machine shut off during use.There was no patient injury reported.

Manufacturer Narrative

The log file was analyzed whereby it was determined that the device passed the automatic power-on self-test (post) in the morning of the date of event without deviations.The respective surgical procedure ran stable and unremarkable until the self-monitoring function detected a communication problem between the cpu board that controls the gas dosage and the user interface.In a situation where ventilator and gas mixer enter a fail state simultaneously the supervisor software routine is designed to switch-off both subsystems.Other than reported the device did not shut itself completely off but went into the so-called "safety mode" and alerted the user to this condition by means of a corresponding alarm.If such deviation would occur during use the user has to set up adequate oxygen and a-gas flows manually to perform manual ventilation with the in-built breathing bag; monitoring functionalities of the device are not affected by this kind of error condition.The procedure how to establish the emergency gas supply is laid down in the ifu.In the particular case the user was able to oercome the situation by rebooting the device; the respective procedure was continued for more than 3 hours without further issues.Dräger knows a certain number of similar events - none of these cases could be traced back to a clear root cause.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.The fact that rebooting the device removed the error condition substantiate the validity of this assessment.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 is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the machine shut off during use.There was no patient injury reported.

• 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: 11025606
• MDR Text Key: 222764544
• Report Number: 9611500-2020-00465
• 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,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1