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

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718 h3 other text : device evaluation anticipated, but not yet begun.

Event Description

The hospital reported an employee was working to replace the inlay at the bottom of the surgical table, when his right hand came across the sharp edge of the inlay causing a laceration to his right hand.The employee reportedly requested stiches.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcareâs (gehc) investigation has been completed.The root cause of the laceration was use error.The gehc employee did not wear cut-resistant gloves during the repair process.Gehc environmental health and safety created a safety communication to create additional awareness that cut-resistant gloves should be worn during the repair process.In addition, as continuous improvement, clarity will be provided in product service manuals for use of protective equipment when performing repairs.

• 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: 17929719
• MDR Text Key: 325571793
• Report Number: 2112667-2023-05321
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/14/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male