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

Device Problems Defective Alarm (1014); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

No further information provided to ge healthcare.The hospital did not contact ge healthcare for service.Patient information could not be obtained due to country privacy laws.Serial number not provided.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Report source other: (b)(6) aer database.Date of device manufacture unknown as no serial number provided.

Event Description

The hospital reported the unit shutdown during a case and failed to alarm.The patient was manually ventilated.There was no 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: 9596511
• MDR Text Key: 219763400
• Report Number: 2112667-2020-00168
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 12/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• 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