MAUDE Adverse Event Report: GENERAL ELECTRIC COMPANY, DATEX-OHMEDA, INC. AESTIVA/5 7900 3VAP US CONFIG ACTIVE AGSS; ANESTHESIA MACHINE

Model Number AMRG02945

Device Problems Inflation Problem (1310); Leak/Splash (1354); Loss of Power (1475)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

A (b)(6) female with end stage renal disease was undergoing a right brachio-brachial arterio-venous forearm loop graft placement.During third part of procedure, the anesthesiologist stated the anesthesia machine was not working and patient was de-saturating.The bellows collapsed, would not re-inflate and showed a leak.Procedure was paused; patient was manually oxygenated by anesthesiologist.Anesthesia tech arrived to room and replaced the patient circuit and flow sensor (did not keep).Anesthesiologist maintained patient saturation above 90 percent and patient fully recovered from anesthesia.

• Brand Name: AESTIVA/5 7900 3VAP US CONFIG ACTIVE AGSS
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): GENERAL ELECTRIC COMPANY, DATEX-OHMEDA, INC. ; ohmeda dr. ; po box 7550; madison WI 53707 7550
• MDR Report Key: 5419738
• MDR Text Key: 38092612
• Report Number: MW5060063
• 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: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AMRG02945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 92