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

Device Problems Device Alarm System (1012); Output Problem (3005)

Patient Problem Death (1802)

Event Date 12/04/2014

Event Type  Death  

Event Description

The customer reports that during a cholecystectomy a carescape b650 in conjunction with the e-caiov gas module did not provide co2 readings nor did it alarm.The patient did not survive the event.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Root cause undetermined.Gas module (e-caiov), and b650 monitor were checked by gehc field engineer and found to function within manufacturing specifications.Gas module was used for one spinal case and monitor with two more cases that day with no further reported complaints.The investigation concludes the device was operating to specification and did not malfunction.

• Brand Name: E-CAIOV
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki, ; FI
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki, 510 ; FI 510
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4414112
• MDR Text Key: 5372670
• Report Number: 9610105-2015-00002
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

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: 02/06/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 64 YR