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

Catalog Number 8606500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

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 dispatched fse could confirm the reported shut-down of the automatic ventilation; the log contains an entry of a motor encoder check error and the resulting shut-down of ventilation including the triggered corresponding vent fail alarm.The two pcbs which control operation of the ventilator and the gas dosage were replaced.The device passed all tests afterwards and could be returned to use.The two pcbs were returned to the manufacturer and installed into the periphery of a lab device for testing.However, no deviation from specification could be found.The motor was also excluded as the root cause already during the on-site evaluation.In general, an encorder check error can be caused by the motor, by the control electronics by e.G.Providing a false driving signal or by the position detection system.Deviations in motor speed and/or position may lead to false piston hubs and, in consequence to potentially hazardous output or to damages of the ventilator unit when the piston is driven against the upper or lower end positons.Thus, the system is designed to shut down automatic ventilation in case of an encoder check error.The position detection system is an optical one facilitating an encoder disc with markings and a light barrier that reads the markings during motor rotation.Dust or particles on the disc or detector may disturb the optical detection and are easy to oversee during repair ingress or are removed unnoticeably.Since the other components can be excluded as the source of deviation, a temporary issue with the position detection system is the remaining likely explanation.Dräger finally concludes that the system responded as designed upon a deviation within the motor encoder system which cannot be further specified.The log file provides evidence that the user continued the procedure as intended in manual ventilation; the monitoring features of the device remain unaffected from the ventilator shut-down.

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: 11397415
• MDR Text Key: 251661493
• Report Number: 9611500-2021-00095
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)191218(17)240528(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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1