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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided with a follow-up report.

Event Description

It was reported that during a case the unit went to a ventilator failure.No 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.The case in question was started at 1:19pm using man/spont and continued in volume af mode from 1:19pm.Until approx.1:55pm ventilation was unremarkable and stable.In the following initially significant circuit leaks of 1.0 l/min were measured and several apnea, volume not attained and fg low or leak alarms were given.In the further course, negative pressures (up to -16 hpa) and positive pressure peaks (up to 94 hpa) 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 of the patient 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.

Event Description

It was reported that during a case the unit went to a ventilator failure.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: 11451100
• MDR Text Key: 256540470
• Report Number: 9611500-2021-00099
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)161102(17)170327(93)8606500-63
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1