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

Model Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was started; results will be provided with the follow-up report.

Event Description

It was reported during a case that the unit displayed a "replace vent" message.There was no patient injury reported.

Manufacturer Narrative

The device has been inspected by a service engineer.The descriped problem could be confirmed.The error codes in the log file indicate that there was a problem with the vacuum pressure inside the ventilator unit.This vacuum pressure is needed to keep the upper piston diaphragm in place to avoid wrinkling during piston movement.The lower piston diaphragm which has a sealing function for the vacuum volume has been replaced.The device passed all consecutive tests and is back in use.The ventilator diaphragm is a detachable component and typically removed for cleaning and disinfection and re-installed after reprocessing by user.An incorrect assembly is widely prevented by the mechanical design of the housing, the diaphragm and the breathing system.Nevertheless, an incorrect assembly can¿t be ruled out totally and seems to be the likely explanation for the particular incident.The log confirms that the workstation posted the corresponding alarm to alert the user.The log confirms that the workstation posted the corresponding alarm to alert the user.

Event Description

It was reported during a case that the unit displayed a "replace vent" message.There was no patient 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
• MDR Report Key: 14300111
• MDR Text Key: 297358780
• Report Number: 9611500-2022-00111
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)170824(17)180121(93)8606500-64
• Combination Product (y/n): N
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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