MAUDE Adverse Event Report: AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The date of manufacture was not available at the time of filing.The distributor performed a checkout of the equipment and confirmed the reported complaint.The bag/vent microswitch was replaced, and the unit was returned to service.

Event Description

The hospital reported a failure of the unit to switch to mechanical ventilation when requested, during preuse checkout.There is no report of patient involvement.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188 ; 2625443620
• MDR Report Key: 7222853
• MDR Text Key: 98529374
• Report Number: 9710602-2018-00026
• 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
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1