AESPIRE VIEW

Report

• Report Number: 2112667-2019-00291
• Event Type: Malfunction
• Date Received: July 15, 2019
• Report Date: July 15, 2019
• Manufacturer: DATEX-OHMEDA, INC.
• Product Code: BSZ
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOR THE REPORTED EVENT, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED EVENT. THE FLOW SENSORS WERE REPLACED TO RESOLVE THE REPORTED ISSUE.

Description of Event or Problem · 1

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 1009-9212-000 ANESTHESIA GAS MACHINE EXPERIENCED DAMAGED FLOW SENSORS PREVENTING MECHANICAL VENTILATION. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
585570	AESPIRE VIEW	ANESTHESIA GAS MACHINE	BSZ	DATEX-OHMEDA, INC.	1009-9212-000

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Patient Involvement

Product problems · 1

• Material Integrity Problem

Type of report · 1

• Initial submission