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

Device Problem Tidal Volume Fluctuations (1634)

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

Event Date 09/30/2021

Event Type  malfunction  

Event Description

During pre-use check, the customer reported a device malfunction resulting in the over-delivery of the set tidal volume.There was no report of patient involvement.

Manufacturer Narrative

The distributor performed a checkout of the equipment and confirmed the reported complaint.The device was calibrated to correct the issue.Block a: patient information could not be obtained due to country privacy laws.Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.H3 other text : the distributor performed a checkout of the equipment and confirmed the reported complaint.The device was calibrated to correct the issue.Block a: patient information could not be obtained due to country privacy laws.Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: elizabeth roedl ; 3030 ohmeda dr,; madison,, WI 53718
• MDR Report Key: 12704371
• MDR Text Key: 280776625
• Report Number: 2112667-2021-02381
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Date Device Manufactured: 05/26/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1