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

Catalog Number 8605310

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

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 vent fail during use.There was no injury reported.

Event Description

Please refer t initial mfr.Report #9611500-2019-00366.

Manufacturer Narrative

An analysis of the device log file was performed.It could be identified that a sporadic deviation with the cpu board which controls the device-internal communication between user interface and gas mixer has caused the reported symptom.Due to the loss of communication, simultaneously, ventilator and gas mixer initiate an emergency shutdown; the device enters the monitoring mode.This condition is alerted to the user by corresponding alarms.Manual ventilation with emergency oxygen dosage and application of anesthetic gas remains possible.Also the monitoring functionalities remain unaffected.Comparable cases of sporadic interruptions of the device-internal communication are known.In these cases it was possible to identify the pcb cpu to be root cause but the sporadic symptom could not be reproduced during detailed investigation of the cpu boards and thus, the exact failure mechanism could not be determined.Also in the particular case a long-term test run of the replaced cpu board revealed no findings.By the fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application a general design failure can be excluded.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 affected board was replaced as a precautionary measure.The device was successfully tested afterwards and was returned to use.The number of similar cases, related to the same root cause, 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: 9271262
• MDR Text Key: 186751497
• Report Number: 9611500-2019-00366
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1