MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE

Device Problems Device Alarm System (1012); Failure to Cycle (1142); Device Displays Incorrect Message (2591)

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

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A ge healthcare field engineer performed a checkout of the system and confirmed the customer allegation.The high powered display unit (hpdu) was replaced and version 8.1 software was loaded.

Event Description

The hospital reported that, during a case, the unit alarmed and mechanical ventilation stopped.There was no reported patient injury.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 5461371
• MDR Text Key: 39459925
• Report Number: 2112667-2016-00353
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1