MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Model Number E-SCAIO-00

Patient Problem Insufficient Information (4580)

Event Date 06/17/2023

Event Type  malfunction  

Event Description

During a daily check, the anesthesia tech noted a gas alarm alert on the e-scaio-00-assembly module.The unit was taken out of service.Ge and biomed aware.Ge took unit and provided a replacement module.

• Brand Name: NA
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 17649868
• MDR Text Key: 322267624
• Report Number: 17649868
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

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 Model Number: E-SCAIO-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Date Report to Manufacturer: 08/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1