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

Model Number 8606500

Device Problems Display or Visual Feedback Problem (1184); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

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 that during a case the device alarmed "ventilator failure".User then switched to man/spont mode.No patient injury reported.

Manufacturer Narrative

As neither the device log file nor additional information could be provided for investigation an analysis of the case in question was not possible and finally the root cause could not be determined.Therefore only a general approach for the case in question was 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 in this case.Based on the initial information it can be assumed that the device reacted as described and thus acc.To specification.The device was tested and was returned to use with no further problems reported since then.

Event Description

It was reported that during a case the device alarmed "ventilator failure".User then switched to man/spont mode.No patient injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 12007604
• MDR Text Key: 259608112
• Report Number: 9611500-2021-00257
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)161107(17)170401(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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1