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

Catalog Number 8606500

Device Problems Degraded (1153); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

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 there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

The device had been examined on-site but did not exhibit any new malfunctions during testing.The failure codes recorded in the error log indicated that two consecutive motor encoder checks have occurred approx.One hour after start of the concerned procedure.The service engineer decided to replace the ventilator motor unit.The device passed all tests afterwards and was returned to use.The original motor was tested in the manufacturer's lab.It was found that reversal of rotation direction was not performed with the required dynamics.The motor drives the piston up and down via a spindle.The number of rotations equals the piston hub and thus, to the volume applied by the ventilator.Motor position, rotating speed and acceleration is being measured continuously and compared with the values calculated by the software.If significant deviations are detected, a shut-down is forced to protect the patient from potentially hazardous output resulting from false piston hubs.Dräger finally concludes that the system responded as designed upon a deviation within one subsystem.Automatic ventilation was shut down for safety reasons; the user was alerted to this condition by means of a corresponding alarm.There is no comparable case known.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

• 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: 10940576
• MDR Text Key: 219351871
• Report Number: 9611500-2020-00445
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200625(17)250306(93)8606500-67
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1