MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported the unit, during preuse checkout, lost the ability to mechanically ventilate.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that this complaint did not cause a loss of mechanical ventilation and is not reportable.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.Additional information was received that this complaint did not cause a loss of mechanical ventilation and is not reportable.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.

• Brand Name: AESTIVA 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7153130
• MDR Text Key: 96056933
• Report Number: 2112667-2017-02411
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/19/2018
• 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