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

Device Problem High Readings (2459)

Patient Problem No Information (3190)

Event Date 04/23/2014

Event Type  Injury  

Event Description

This customer reports that the e-caio gas module provided inaccurately high fico2 and etco2 readings during a procedure.The patient was manually bagged with an ambu bag and medicated with propofol.No further consequences to the patient.

Manufacturer Narrative

Patient data not currently available.Email address of reporter unknown.Date of manufacture unknown at this time.A follow-up report will be submitted when the investigation is complete.

• Brand Name: E-CAIO
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; helsinki ; FI
• Manufacturer (Section G): GE HEALTHCARE
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy.; barrington, IL 60010 ; 8472774472
• MDR Report Key: 3850600
• MDR Text Key: 16597571
• Report Number: 9610105-2014-00012
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/23/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention