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

Model Number 1009-9000-000

Device Problems Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The adjustable pressure limiting valve was replaced, and the unit was returned to service.

Event Description

The hospital reported the adjustable pressure limiting valve became detached causing a loss of manual ventilation.There was no report of patient involvement.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski
• MDR Report Key: 9484055
• MDR Text Key: 219763398
• Report Number: 2112667-2019-02624
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9000-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2004
• 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