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

Catalog Number 8606500

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

Patient Problem Cough (4457)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported during a case the patient was being rolled from their stomach to their back.The patient was coughing during the roll.The patient was reconnected and at that point the apollo unit was showing a ventilator failure message.The patient was bagged for the remainder of the case and there was no injury reported.

Manufacturer Narrative

A dräger technician evaluated the device in follow-up of the event, the logfile was provided for the investigation.The unit was tested and confirmed to be operating per manufacturer's specifications.Log file evaluation revealed that the automatic power-on self-test was passed in the morning without deviations.The concerned surgical procedure went widely stable until a significant circuit leak was present reflected in several apnea alarms given and resulting in a fresh gas deficiency.At this point the patient most likely was rolled their stomach to their back.One minute later a too fast and too high pressure increase was detected resulting in an emergency shutdown while autonomously changing mode to man/spont.The shutdown was accompanied by the corresponding ventilator fail alarm.The therapy was continued using manual ventilation until the unit was placed in standby.All in all, no indication for the potential presence of a device malfunction could be found.The safety shut-down was triggered by a transient pressure peak in the airway system.Since the user described that the patient coughed during the event, a reasonable explanation would be that the patient was coughing in a moment where the ventilator piston was moving upwards.To protect from potentially hazardous output, the device is designed to shut-down automatic ventilation when such fast and significant rise in airway pressure is detected.Dräger finally concluded that the device behaved according to specification.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14546070
• MDR Text Key: 297361883
• Report Number: 9611500-2022-00127
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1