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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated on-site.The reported ventilator failure could be confirmed and traced back to an error condition in the piston position detection system.The hub of the piston is equivalent to the tidal volume the ventilator applies.If the piston position cannot be detected anymore the device is designed to shut down automatic ventilation to protect from potentially hazardous output.The shut-down is accompanied by a corresponding alarm; manual ventilation and the monitoring functions remain available to the full extent.The dräger service engineer replaced the photodetector in the light barrier system to rectify the problem.The device passed all consecutive tests and could be returned to use.Dräger finally concludes that the system responded as designed upon the malfunction of a single component that occurred after 16 years of use.

Event Description

It was reported during a case that the device displayed a ventilator failure message.There was no patient injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported during a case that the device displayed a ventilator failure 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: 12717794
• MDR Text Key: 280877341
• Report Number: 9611500-2021-00445
• 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,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2005
• 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