MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA APOLLO; GAS-MACHINE, ANESTHESIA

Model Number 8606500

Device Problems Loose or Intermittent Connection (1371); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Patient intubated when ventilator stopped working properly, anesthesia had to bag patient manually and change modes to get ventilator to reset itself.Biomed investigated, per notes: "verified no mechanical failures in the event logs.Staff member said that inspiratory flow sensor was installed but the cover on the breathing system was loose.She stated that the mechanical ventilation was not delivering gasses as it should.After testing the unit in different modes, i verified the functioning of the unit works and no problems were detected.I determined the issues were due to the loose inspiratory flow sensor cover which would've leaked gas that should have been delivered to patient, but was being released to ambient air.Anesthesia machine works as should and is okay for service.".

• Brand Name: APOLLO
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 6 tech drive; andover MA 01810
• MDR Report Key: 12655979
• MDR Text Key: 277128063
• Report Number: 12655979
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/30/2021,03/22/2021

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 Model Number: 8606500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1