MAUDE Adverse Event Report: AESPIRE VIEW; ANESTHESIA GAS MACHINE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the tidal volume was not being achieved.There was no report of patient involvement.

Manufacturer Narrative

The breathing system and tubings were cleaned and reset the exhalation valve and solenoid valve to resolve the reported issue.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• MDR Report Key: 12655980
• MDR Text Key: 279564988
• Report Number: 2112667-2021-02320
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

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: 09/20/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 10/27/2021
• Supplement Dates FDA Received: 10/20/2021; 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2010
• 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