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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was a vent fail during a case.This did not lead to patient injury, reportedly.

Event Description

It was reported there was a vent fail during a case - this did not lead to patient injury, reportedly.

Manufacturer Narrative

Upon initial log file analysis the dispatched fse could confirm the occurrence of a ventilator failure during the concerned procedure.Based on the error codes found, the entire ventilator subsystem was replaced.The device passed all consecutive tests and was returned to use.The replaced parts were inspected and tested in the manufacturer's lab.Visual examination revealed that the ventilator motor and the position encoder system were covered with a grey powdery substance; the origin of this substance could not be clarified.It was further determined that, during rotation of the motor, some impulses from the encoder disc were missing.Only if all impulses are detected this is signalizing a complete rotation of the encoder disc.The presence of the foreign substance explains why the optical position detection was impaired which was then leading to an encoder check error.To prevent from potentially hazardous output or severe mechanical damages to the ventilator the system is designed to respond to such an encoder check error with a shut-down of automatic ventilation; a corresponding alarm will be posted.Based on the reported observations and the findings in the log dräger finally concludes that the device reacted upon the deviation as specified.

Event Description

It was reported there was a vent fail during a case - this did not lead to patient injury, reportedly.

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.

• 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: 13024098
• MDR Text Key: 284289181
• Report Number: 9611500-2021-00511
• 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,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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