MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

Model Number 1006-9305-000

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The battery was replaced to resolve the reported issue.No patient information provided to date after calls to customer 07/01/20, 07/06/20, and 07/07/20.

Event Description

The hospital reported short battery life during patient use.No report of patient injury.

• Brand Name: AESTIVA 7900
• 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: 10240855
• MDR Text Key: 202047149
• Report Number: 2112667-2020-01873
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1006-9305-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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