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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device posted a ¿reinstall ventilator¿ alarm during use.There was no injury reported.

Manufacturer Narrative

The log file indicates that the power-on self-test (post) could not be passed on the date of event until a too high leakage in the automatic ventilation path of the breathing system could be resolved.The case in question was suffering from the beginning of automatic ventilation at 09:47 am from an expiratory flow during inspiration phase.The device alarmed for reinstall vent as described by the complainant.Due to the leak the applied volumes and resulting airway pressures were occasionally reduced and the device additionally alarmed at times for apnea and pinsp not attained.After changing to man / spont at 10:51am the device was powered off at 11:15 am.Based on experience, an expiratory gas flow during inspiration is either related to a too slow reacting electronic peep control loop which causes a delayed closure of the pneumatic peep valve or to humidity or other similar factors that hinder the correct movement of the pneumatic peep valve.Since the issue could not be duplicated during testing in follow-up of the event, the exact root cause could not be determined.In general, a sticking peep valve is detected during automatic post.If the corresponding test step fails, an appropriate message is displayed on the screen.The specified device behavior for occurrence during a running ventilation episode is exactly as described for the particular case - corresponding's alarms will be posted; manual ventilation and monitoring functions are not affected.

Event Description

Please refer to initial mfr.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: 10318968
• MDR Text Key: 200437361
• Report Number: 9611500-2020-00260
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1