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

Model Number E-SCAIO-00

Device Problem Defective Device (2588)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Ge healthcare e-scaio-00 co2 modules (part#: m1184092) on anesthesia machine are failing over the last 2 weeks.Eight ge healthcare e-scaio-00 co2 modules have failed.The routine checks are performed before the patient gets into the operating room.We have alerted biomed as well as ge, the vendor of the machines.Still waiting to hear back if there is any form of recall or if they are just all reaching end of life for the components.Per anesthesiologist: the anesthesia machine checks are typically run each morning (or overnight) by an anesthesia tech.Between each case, the "circuit check" is run testing that the freshly placed breathing circuit is functional.The anesthesia machine checks are not often going to detect a problem with the co2 sampling modules.Errors with these usually present themselves only when connected to a patient (whom is exhaling co2 and oxygen, and anesthetic gases for detection).

• 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: 16610268
• MDR Text Key: 311959374
• Report Number: 16610268
• 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: 03/07/2023

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: Other
• 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: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1