MAUDE Adverse Event Report: DRAEGERWERK AG AND CO KGAA APOLLO ANESTHESIA MACHINE

Model Number APOLLO

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 02/16/2017

Event Type  No Answer Provided  

Event Description

Following open heart procedure, while pt still in the operating room and connected to the anesthesia machine, patient's sao2 and bp were dropping.At this time the physician and the staff did not hear any audible alarms being triggered on the anesthesia machine.No adverse effect to the patient as a result of this event.Equipment tested by (b)(6) hospital clinical tech, department as well as field service engineer of the mfr.Internal and external investigation deemed equipment to be functioning per mfr specifications.

• Brand Name: APOLLO ANESTHESIA MACHINE
• Type of Device: APOLLO ANESTHESIA MACHINE
• Manufacturer (Section D): DRAEGERWERK AG AND CO KGAA
• MDR Report Key: 6453138
• MDR Text Key: 71689440
• Report Number: MW5068848
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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 Age: 74 YR
• Patient Weight: 100