MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA MRI; ANESTHESIA GAS MACHINE

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.This complaint is not serial # dependent but rather refers to all aisys cs2 mri product wherein the flow sensors have a manufacture date of 2021-06 or later.As this is not serial number specific, there is no specific udi number.Date of device manufacture: the date of device manufacture is prior to june 2021 as the fault was identified to have occurred in flow sensors manufactured prior to june 2021.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 28 july 2021 under report number (b)(4).Customers were sent a letter explaining the issue and were provided the following safety instructions: always complete a pre-use checkout, including circuit leak test or breathing system tests, on your anesthesia machine prior to use.Follow instructions in the anesthesia machine users reference manual sections for a preoperative checkout and a preoperative test review all inventory of flow sensors, including those installed in anesthesia machines, in spare inventory, in reprocessing locations, and other locations not in use.Take care while handling flow sensors during removal, insertion, reprocessing, storing, or other types of handling, as damage could occur to the tubing and create cuts or punctures that affect flow sensor performance.

Event Description

Ge healthcare internally identified damage to the flow sensor tubing which may cause leaks resulting in incorrect anesthesia machine tidal volumes.This can lead to potential over-delivery of volume to the patient.No patient involvement reported.

• Brand Name: AESTIVA MRI
• 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: john szalinski ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 12239411
• MDR Text Key: 265998278
• Report Number: 2112667-2021-01784
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/28/2021

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: 06/30/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2126677-07/28/21-006-C
• Patient Sequence Number: 1