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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that the device had a ventilator failure during use.No patient injury has reportedly occurred.

Manufacturer Narrative

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

Manufacturer Narrative

The device is not under a service contract.The customer submitted log files and was seeking dräger's assistance.Review of the log entries revealed that the device passed the power-on self test in the morning of the doe without deviations.It could further be revealed that the concerned procedure went stable and unremarkable for the first 30 minutes until the supervisor function of the software detected a drop in the auxiliary vacuum pressure and responded to that with the corresponding alarm reinstall ventilator.The user switched forth and back between certain different ventilation modes but this did not remedy the issue; the device was finally set to standby then.The auxiliary vacuum pressure is needed to keep the ventilator piston diaphragm in place to avoid wrinkling and to prevent from damages to the ventilator unit.The drop in vacuum pressure may be related to certain different conditions.Since it is known that a preventive maintenance ingress was made by inhouse personnel before, it is seen likely that the lower piston diaphragm was incorrectly installed during the maintenance and became punctured during the first half hour of ventilator operation which led to loss of vacuum pressure then.Other than reported the automatic ventilation did not stop but was significantly impaired.Dräger provided feedback to the customer with an instruction what to check to identify the root cause.No response was received.Finally, dräger concludes that the device responded as designed upon the drop in vacuum pressure and posted the corresponding alarm.

Event Description

It was reported that the device had a ventilator failure during use.No patient injury has reportedly occurred.

• 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: 18985052
• MDR Text Key: 338724799
• Report Number: 9611500-2024-00133
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)171201(17)180429(93)8606500-64
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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
• Treatment: NA.; NA.