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

Catalog Number 8606500

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

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 there was a ventilator failure message during pressure support mode.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2020-00216.

Manufacturer Narrative

The initial log file evaluation carried out at the installation site indicated that the supervisor software of the workstation detected a wrong piston position and forced a shutdown of automatic ventilation to prevent from damages to the ventilator unit.The shutdown is accompanied by a corresponding alarm to alert the user.Log file entries further demonstrate that the users were able to finish the surgery by using manual ventilation.Upon the findings the dräger fse decided to replace the ventilator motor including the position detection system.The device was tested afterwards, found fully compliant to specifications and was returned to use.The replaced parts were subject to in-depth testing in the manufacturer's lab.Neither the motor nor the position detection system (optical encoder disc and light barrier) exhibited deviations from specification.A sporadic malfunction may have occurred - it is however considered more likely that no technical deviation has caused the shutdown.In fact, it was reported that the patient was tachypnic at the time of event.Repositioning of the patient, pressure applied to the chest, manipulation of the breathing hoses etc.During operator intervention may have caused a pressure surge in the pneumatic circuit against the movement of the ventilator piston.Such a scenario may also lead to shutdown of automatic ventilation and, it is in the nature of things that no traces at the hardware can be found in follow-up of the event.Dräger finally concludes that the device responded as designed upon a disturbance of unknown origin; ventilation was shut down to protect the patient from potentially hazardous output and to prevent from damages to the ventilator unit which may result in consequence of a wrong piston position.The appropriate alarm was posted and manual ventilation as well as the monitoring functionalities remained available.

• 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: 10216779
• MDR Text Key: 198707610
• Report Number: 9611500-2020-00216
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)181206(17)190503(93)8606500-65
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1