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

Catalog Number 8506500

Device Problems Failure to Deliver (2338); Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.

Event Description

It was reported that there was a gas delivery and ventilator failure alarm during use.There was no patient injury reported.

Event Description

Please see initial report.

Manufacturer Narrative

The electronic logfile was available for investigation.The information stored therein indicate that a sporadic internal communication problem of the ventilator¿s cpu board was the root cause for the reported event.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.

• 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: 9692474
• MDR Text Key: 178550790
• Report Number: 9611500-2020-00036
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8506500
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1