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

Catalog Number 8606500

Device Problem Failure to Deliver (2338)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

It was further noticed that the user was unable to run device self-tests just after the reported event.The affected device was repaired on site and the replaced parts and device logs were submitted to the manufacturer for further analysis.The investigation of device logs confirmed the reported loss of ventilation and the switch over to manual ventilation.The analysis of the replaced parts confirmed a component failure of the electronic board for the motor control.The quality data of the identified failed component does not show conspicuousness - so the case was assessed as an isolated case.Finally the manufacturer confirms the reported event and note that the device behaved as specified, alarmed the detected malfunction and switch over to manual ventilation was possible and confirmed by the user.

Event Description

It was reported that during use on a patient the ventilator stopped, generated alarm and a device message "ventilator piston problem" was displayed.The patient was manually bagged without further consequences - i.E.No injury or serious impairment of patient´s health was 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: 18657326
• MDR Text Key: 334722403
• Report Number: 9611500-2024-00043
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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