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

Catalog Number 8606500

Device Problems No Pressure (2994); Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided within a separate follow-up report.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

Since neither the requested logfile nor the parts were returned, a detailed analysis of the case in question as well as the determination of the root cause was not possible.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.Based on the available information, the root cause for the reported ventilator failure could not be determined but it can be assumed that the device reacted as specified with an autonomous change to manual ventilation and alarmed audible and visible for ventilator fail.

Event Description

Please refer to the initial-report.

• 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: 7599921
• MDR Text Key: 111709954
• Report Number: 9611500-2018-00204
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1