MAUDE Adverse Event Report: GE HEALTHCARE GE DATEX -OHMEDA GAS ANALYZER E-CAIO; DATEX-OMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIO,

Model Number FGDX1100

Device Problems Incorrect Measurement (1383); Device Sensing Problem (2917)

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

Event Date 11/17/2020

Event Type  malfunction  

Event Description

Reportedly, post repair, the device was not recognizing and its fyo2 readings were at 0%.The complaint states that the device was being used in an endo case and the patient was under light sedation.Additional measures were put in place to monitor that patient and no harm came to the patient while the unit was in use.The physician used secondary units in place in case of primary unit failure.There was no patient harm or medical intervention.No additional information is available.

Manufacturer Narrative

The complaint states that the device was being used in an endo case and the patient was under light sedation.Additional measures were put in place to monitor that patient and no harm came to the patient while the unit was in use.The physician used secondary units in place in case of primary unit failure.The complaint device was returned for evaluation.Technical evaluation identified tpx and 02 module failures.The customer complaint was confirmed; however, the failures identified were not related to a previous service or repair.The root cause for the reported event was determined to be an intermittent issue resulting in the device not being detected.No additional information is available.This type of event will continue to be monitored.

• Brand Name: GE DATEX -OHMEDA GAS ANALYZER E-CAIO
• Type of Device: DATEX-OMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIO,
• Manufacturer (Section D): GE HEALTHCARE; 86 pilgrim road; needham MA 02492
• MDR Report Key: 10993673
• MDR Text Key: 221539740
• Report Number: 3007409280-2020-00052
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): Y
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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: Health Professional
• Device Model Number: FGDX1100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1