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 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

The log file was available for investigation.Negative pressure (up to -17 hpa) and positive pressure peaks (up to 98 hpa) were logged.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 a ventilator fail alarm.Possibly a suction system was used.It¿s also conceivable, that the patient was coughing at the time of event.The logfile analysis has shown no indications for a technical malfunction.Root cause for the reported symptom was an overpressure at the patient end of the circuit leading to a pressure peak and thus to an emergency shutdown of the ventilator.The device reacted as specified with an autonomous shutdown of the ventilator and alarmed audible and visible for ventilator fail while autonomously changing to manual ventilation (man/spont).Manual ventilation remained unaffected, as specified.

Event Description

It was reported that the machine had a vent fail message come up.Anesthesia had to bag the patient until the end of the case.No injury reported.

• 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: 17718862
• MDR Text Key: 323053994
• Report Number: 9611500-2023-00314
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)221124(17)270427
• 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
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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