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

Catalog Number 8603800

Device Problems Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device stopped operating with a ¿green screen¿ during a procedure.There was no injury reported.

Manufacturer Narrative

A dräger service technician has examined the devie on-site and could confirm that the device software was stuck, unable to complete the boot sequence.The technician replaced the pcb which controls user interface and display.The workstation passed all the consecutive tests and could be returned to use.The root cause for the issue could not be conclusively determined.A disturbance from external like esd or other electromagnetic event that exceeded the immunity barriers of the device seems to be likely.If such issue occurs, the device issues a buzzer alarm for at least 30 seconds to alert the user; manual ventilation with the built-in breathing bag remains possible.No patient consequences have been reported for the particular case.

Event Description

It was reported that the device stopped operating with a ¿green screen¿ during a procedure.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 23542 ; GM 23542
• MDR Report Key: 10867307
• MDR Text Key: 217103308
• Report Number: 9611500-2020-00421
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1