MAUDE Adverse Event Report: DRAEGER DRAEGER APOLLO; GAS MACHINE, ANESTHESIA

Model Number APOLLO

Device Problem Device Maintenance Issue (1379)

Patient Problem No Information (3190)

Event Date 04/11/2018

Event Type  malfunction  

Event Description

Draeger can not deliver preventive maintenance kits for their apollo anesthesia units.Pm kits not available at this time.Resulting in delayed pm completion to high risk equipment.Pm replacement 3 yr - (b)(6) 2018.Pm kit 2yr - (b)(6) 2018.

• Brand Name: DRAEGER APOLLO
• Type of Device: GAS MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER; denver CO 80124
• MDR Report Key: 7432324
• MDR Text Key: 105756357
• Report Number: MW5076500
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: APOLLO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other