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

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

Unable to complete preventative maintenance (pm) on 3 (three) anesthesia machines per the schedule set out by the oem due to no available pm kits.Site has safety and regulatory concerns due to missed maintenance for devices as they are life support devices.Back order issues with oem put patients at risk.Serial numbers: (b)(4).Fda safety report id# (b)(4).

• Brand Name: APOLLO
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 15633130
• MDR Text Key: 302174323
• Report Number: MW5112738
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/17/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other