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

Device Problem Crack (1135)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.However this failure was discovered during patient use, which may mean the canister had to be replaced during the procedure.The biomedical technician noticed the cracked canister lid during a review of the unit after the case.The manufacturer was contacted for replacement.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).

Event Description

Per (b)(6) aer database: it was reported the absorbent canister would not latch to the unit during patient use.The anesthesia unit was replaced and the surgery was completed without injury or harm to the patient.

• 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: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 13307240
• MDR Text Key: 287259473
• Report Number: 2112667-2022-00137
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/20/2022
• Date Device Manufactured: 07/28/2017
• 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