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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that during a case, the unit posted a ventilator failure.There was no injury reported.

Manufacturer Narrative

The device was tested on-site in follow-up of the event and did not show any persisting malfunctions.All tests were passed and, the unit was released for doing service on patients again.Log file review provided by the manufacturer confirmed a temporary issue that matches with the reported observation: the power-on self-test was passed without deviations in the morning of the date of event.The concerned procedure went stable and unremarkable in the beginning until the signal from the sensor that monitors the pressure inside the cylinder of the piston ventilator got lost or entered an implausible value.To prevent from potentially hazardous output the device is designed to force a safety shut-down of automatic ventilation and to post a corresponding alarm.The user bridged patient support in manual ventilation with the built-in breathing bag for 5 minutes and switched than back to pressure support mode which was successful - the pressure sensor signal had obviously returned to plausible values.The procedure was continued for 15 more minutes without further problems before the device was put into standby.The exact root cause of the problem could not be determined; a reasonable explanation however would be that humidity has disturbed the sensor signal.Dräger finally concludes that the device behaved as specified upon a disturbance of temporary nature.No patient consequences have occurred.

Event Description

It is reported that during a case the unit posted a ventilator failure.There was no injury reported.

• Brand Name: APOLLO
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11445647
• MDR Text Key: 263487933
• Report Number: 9611500-2021-00101
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: 010404867522967411160527
• 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: 04/12/2021

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
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1