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

Catalog Number 8605310

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Output Problem (3005); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported while ventilating the patient in pressure control mode, patient table position was changed by 90 degrees, necessitating circuit disconnect resulting in brief apnea condition.Almost contemporaneously clinician increased fresh gas flow, soon after re-establishing circuit connection ventilator fail alarm occurred.Event occurred about 09:00am on (b)(6) 2020.No patient injury reported.

Manufacturer Narrative

A hospital biomed tested the device after the reported event without findings.The log was downloaded and submitted for further analysis.Based on the information stored therein, the case in question could be reconstructed.It was started at 8:29am using man/spont and continued in pressure support mode from 8:40am.At 8:53am a circuit leak of 2.7 l/min was detected, leading to a fresh gas deficit in the following.Some seconds later, the ventilator detected an unexpected pressure peak of around 97 hpa at the patient end of the breathing circuit.Subsequently, negative pressures and positive pressure peaks were alternating and finally, 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.It is very plausible that the reported repositioning activities were the root cause of the unstable pressure situation at the time of event.The investigation has not revealed any device failure.The apollo reacted as specified by stopping automatic ventilation and generating a corresponding alarm.The device was tested and has been used since then with no further problems reported.Further actions are not necessary.

Event Description

It was reported while ventilating the patient in pressure control mode, patient table position was changed by 90 degrees, necessitating circuit disconnect resulting in brief apnea condition.Almost contemporaneously clinician increased fresh gas flow, soon after reestablishing circuit connection ventilator fail alarm occurred.Event occurred about 09:00am on (b)(6) 2020.No patient 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: 10783322
• MDR Text Key: 214579943
• Report Number: 9611500-2020-00392
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1