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

Catalog Number 8606500

Device Problems Degraded (1153); Failure to Deliver (2338); No Pressure (2994)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.We will provide results within a separate follow-up report.

Event Description

It was reported that the apollo posted a ventilator failure duing use.There was no injury reported.

Manufacturer Narrative

The electronic log file and the replaced motor were available for investigation.The reported ventilator failure could be reconstructed by means of the information stored in the log file.During the case in question, the apollo detected a deviation between the measured and the expected position of the ventilator piston.The device reacted in accordance with its implemented safety concept as it interrupted automatic ventilation, switched to man/spont mode and generated a corresponding audible and visible ventilator fail alarm.In such case both manual ventilation and monitoring functions will remain unaffected and available.Hence, the user is able to ventilate the patient manually and monitor relevant information regarding ventilation and gas delivery.The returned motor was inspected in the laboratory.It ran freely and no failure of the position detection system was identified.But unusual noices were observed when running the motor indicating faulty motor brushes or springs which most likely caused the detected deviation between measured and expected piston position.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

Event Description

It was reported that the apollo posted a ventilator failure duing use.There was 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: 18901588
• MDR Text Key: 337644559
• Report Number: 9611500-2024-00111
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)190528(17)191024(93)8606500-66
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• 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