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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

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.The distributor performed a checkout of the equipment and confirmed the reported complaint.The field engineer reinstalled the soda lime canister and cleaned the breathing system to resolve the issue.

Event Description

The hospital reported that the tidal volume was not being achieved due to a leak greater than 4.5 lpm.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 ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 10143514
• MDR Text Key: 194807624
• Report Number: 2112667-2020-01695
• 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: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 06/11/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/11/2020
• Date Device Manufactured: 02/26/2007
• 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