• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2 ANESTHESIA GAS MACHINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATEX-OHMEDA, INC. AISYS CS2 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1011-9050-000
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2020
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. This complaint is not serial # dependent but rather refers to all aisys cs2 product wherein the flow sensors have a manufacture date of (b)(6) 2020. As this is not serial number specific, there is no specific udi number. Date of device manufacture: the date of device manufacture is (b)(6) 2020 as the fault was identified to have occurred in flow sensors manufactured in (b)(6) 2020. Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on (b)(6) 2020. The ge healthcare field action number is fmi34109. 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 preoperative checkout쳌 and preoperative tests. Review all inventory of flow sensors, including those installed in anesthesia machines, in spare inventory, in reprocessing locations, and other locations not in use. Inspect your flow sensors for the date of manufacture etched on the flow sensor body as shown in the examples below. (photo of flow sensors provided on urgent medical device correction letter). Important: the packaging date of manufacture should not be used for this inspection, as it could vary from the date etched on the flow sensor body. Flow sensors should be taken out of their packaging for inspection. Complete and return the attached customer response쳌 form. A. If the date of manufacture is not equal to (b)(6) 2020. (continued on page 3).
 
Event Description
Ge healthcare internally identified damage to the flow sensor tubing which may cause leaks which alter the differential pressure, resulting in incorrect tidal volumes being displayed by the anesthesia machine. This can lead to potential over-delivery of volume to the patient. No patient involvement reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAISYS CS2
Type of DeviceANESTHESIA 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 Key10618091
MDR Text Key210197941
Report Number2112667-2020-02749
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132530
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 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1011-9050-000
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 Received09/03/2020
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 NumberSEEH10

-
-