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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that the unit had a ventilator failure during a case.No reported injury.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the log file analysis the ventilator sporadically detected an expiratory flow during inspiration (pmax valve err).It can be assumed, that a (temporarily) too slow electronic peep valve (mv1) caused a delayed closure of the pneumatic peep valve.In consequence, the device alarmed for reinstall vent, as reported.The applied volumes and resulting airway pressures were occasionally reduced.No indication for a faulty ventilator motor was given.A sticking/stucking peep valve is detected during automatic power-on-self-test.During automatic ventilation, pressure control might be disturbed, as consequence airway pressures, tidal and minute volumes deviating from user settings are possible.Depending on the set alarm limits, alarms regarding inspiratory pressure and/or tidal/minute volume will be generated, as well as technical alarms.Manual ventilation and monitoring functions are not affected.

Event Description

It was reported that the unit had a ventilator failure during a case.No reported injury.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17963306
• MDR Text Key: 326121551
• Report Number: 9611500-2023-00371
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1