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

Device Problems Failure to Run on Battery (1466); Device Displays Incorrect Message (2591)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare (gehc) reported a field modification for this battery issue per 21 cfr 806 on 21-apr-2022.The fda recall number is z-1285-2022, z-1286-2022.Customers were sent a letter explaining the issue and requesting the customer to perform the battery performance test to determine if their batteries may be impacted.Gehc will provide battery replacements, updated user manual for battery capacity testing, battery preventative replacement frequency, and potentially new software based on the product model.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

As a result of an inspection that was completed as part of correction and removal initiated by ge healthcare (gehc) on 21-apr-2022 (recall no.Z-1285-2022, z-1286-2022), this unit was identified as having a battery performance that indicates it may be impacted by the issue described in the recall no.Z-1285-2022, z-1286-2022.There was no patient involvement.

• Brand Name: AISYS CS2
• 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: 16733069
• MDR Text Key: 313255652
• Report Number: 2112667-2023-01977
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BL
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: Z-1285-2022, Z-1286-2022
• Patient Sequence Number: 1