MAUDE Adverse Event Report: DRAEGER APOLLO ANESTHESIA MACHINE

Model Number ASAB-007

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2016

Event Type  malfunction  

Event Description

The draeger apollo anesthesia machine stopped working in the middle of the case.The screen went blank.The anesthesia providers bagged the patient, switched from volume mode to pressure mode and the machine began to work again.Doctor's oxygen was called to repair machine.

• Brand Name: APOLLO ANESTHESIA MACHINE
• Type of Device: APOLLO ANESTHESIA MACHINE
• Manufacturer (Section D): DRAEGER
• MDR Report Key: 5427990
• MDR Text Key: 38084556
• Report Number: MW5060090
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASAB-007
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR