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

Lot Number AMXK01041

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The bag/vent microswitch was replaced, and the unit was returned to service.Block a: 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.Date of device manufacture year is 2006.The month of manufacture was unavailable at time of mdr filing.

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 (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: amanda daly ; 3030 ohmeda dr,; madison, WI
• MDR Report Key: 7329931
• MDR Text Key: 102110203
• Report Number: 2112667-2018-00529
• 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: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: AMXK01041
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2018
• 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