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

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.

• Brand Name: AISYS CS2
• 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: 10618091
• MDR Text Key: 210197941
• Report Number: 2112667-2020-02749
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132530
• 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: 10/01/2020

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: No Information
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 10/01/2020
• 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: N
• Removal/Correction Number: SEEH10
• Patient Sequence Number: 1