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

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

The distributor performed a checkout of the equipment and confirmed the reported complaint.The ventilator monitoring board assembly was reconnected, and the unit was returned to service.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported the unit had a large leak.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the reported fault affected the monitoring of patient data however it did not affect the unit's actual delivery of adequate ventilation.Flow sensors are a customer replaceable item.Unit continues to ventilate and alarms remain functional.Clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.The initial event was not reportable.Additional information was received that the reported fault affected the monitoring of patient data however it did not affect the unit's actual delivery of adequate ventilation.Flow sensors are a customer replaceable item.Unit continues to ventilate and alarms remain functional.Clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.The initial event was not reportable.

• Brand Name: AESPIRE 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: 7374500
• MDR Text Key: 103592425
• Report Number: 2112667-2018-00632
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• 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
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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