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

Device Problem Defective Alarm (1014)

Patient Problem Cardiac Arrest (1762)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and a review of the logs.There was no fault found with the unit and the logs were inconclusive if there was an issue due to machine malfunction, user error, or any other external issue.The unit was returned to service.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.

Event Description

The hospital reported the patient suffered a cardiac arrest at the end of a case.No alarms were noted.The patient has recovered from the cardiac arrest no health consequences.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8013652
• MDR Text Key: 125281292
• Report Number: 2112667-2018-02135
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K092864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2012
• 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