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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AESTIVA MRI ANESTHESIA GAS MACHINE Back to Search Results
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.
 
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Brand NameAESTIVA MRI
Type of DeviceANESTHESIA 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 Key12239411
MDR Text Key265998278
Report Number2112667-2021-01784
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172045
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/30/2021
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
Removal/Correction Number2126677-07/28/21-006-C

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