MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS

Model Number AISYS

Device Problems Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/10/2015

Event Type  Injury  

Event Description

The vaporizer for the anesthesia machine was switched out during surgery.The alarm on the machine and the vaporizer shut off automatically after a short period of time.The process is reliant on human factors, i.E.The anesthesiologist to manually acknowledge and activate the vaporizer.Due to a distraction, anesthesia did not notice the vaporizer had shut off and there was no additional warning from the machine.Patient was not getting the agent necessary to maintain anesthesia and woke during the surgery.

• Brand Name: AISYS
• Type of Device: AISYS
• Manufacturer (Section D): DATEX-OHMEDA, INC.; pittsburg PA 15264
• MDR Report Key: 5471179
• MDR Text Key: 39440678
• Report Number: MW5060644
• 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: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AISYS
• Other Device ID Number: KNO34197
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 102