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

Device Problems Gas Output Problem (1266); Loose or Intermittent Connection (1371); Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Gas/Air Leak (2946); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that the apollo displayed a "reinstall vent" message during use.No patient injury reported.

Manufacturer Narrative

The observed alarm type "reinstall vent" indicates that the device detected a mismatch of >25% between the volume delivered by the ventilator and the one measured by the inspiratory flow sensor.This indicates the presence of a leakage between the ventilator and the inspiratory port of the breathing system.The log file analysis revealed that the concerned rocedure was started in man/spont first with switchover to volume mode after 14 minutes.The automatic ventilation went stable and unremarkable for more than 30 minutes until the aforementioned condition occurred and triggered the observed alarm.The user performed some troubleshooting which did not rectify the problem, switched back to manual ventilation and finally placed the device in to standby after another 14 minutes.Dräger concludes from the sudden occurrence that the issue is most likely related to a leak at the inspiratory nozzle (elbow connector where the patient circuit has to be connected to).If the nozzle is not tightenly screwed, this will lead to a significant leakage between the flow sensor cuvette and the sealing o-ring.Due to movement of the connected patient circuit the leakage varies, thus leading to sporadic alarms only.The dispatched fse has checked the device, replaced some other worn parts as well and released the workstation for further use.No additional symptoms have been reported since then.Dräger finally concludes that the device responded as designed upon the particular deviation; the apropriate alarm was posted.All alarms, potential root causes and dedicated remedies are listed in the ifu.

Event Description

It was reported that the apollo displayed a "reinstall vent" message during use.No patient injury reported.

• Brand Name: APOLLO
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10703715
• MDR Text Key: 212326250
• Report Number: 9611500-2020-00363
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1