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

Catalog Number 8606500

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation was carried out based on the available information and electronic device logfile of the involved anesthesia device.Based on this, the reported shut down could be understood.In case of a ventilator failure during automatic ventilation, the ventilator initiates an autonomous shutdown while changing mode to man/spont (safety mode) and generating the appropriate ventilator fail alarm.Manual ventilation remains possible, as it was in this specific case.It was found that, on the reported date of event, the device was powered on at 7:26 am and the subsequent power-on self-test (post) has been successfully completed at 7:30 am.The case in question was started at 1:37 pm using man/spont and continued in volume af mode from 1:46 pm.Amongst others, the device alarmed repeatedly for volume not attained, fg low or leak, apnea and pressure high in the following and the resulting tidal volumes were widely varying.At 1:56 pm an unexpected pressure peak of 92.3 hpa at the patient end of the breathing circuit was detected and both, negative pressures and positive pressure peaks alternated.Then, due to a too fast and too high pressure increase, the ventilator performed an emergency shutdown while autonomously changing mode to man/spont and generating the respective ventilator fail alarm according to its specifications.The case was continued using man/spont until 2:00 pm, when the device was rebooted.After successful completion of the subsequent post at 2:05 pm, ventilation was continued in pressure mode and ventilation was unremarkable until end of operation.Finally, no indication for a malfunction could be found; the device reacted as specified in this case in question.The root cause for the reported symptom most likely was an overpressure at the patient end of the circuit leading to a pressure peak and thus to the emergency shutdown of the ventilator.It is possible that the patient was coughing against the ventilator or a bronchial suction system was used leading to a pressure disturbance.

Event Description

It was reported in the middle of a case that the apollo shut down.The machine was rebooted and the case was completed without patient incident.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck, 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck, 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck, 23542 ; GM 23542
• MDR Report Key: 7702150
• MDR Text Key: 114414310
• Report Number: 9611500-2018-00227
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• 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: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• 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