MAUDE Adverse Event Report: MARQUETTE ELECTRONICS, INC. GE SAM GAS ANALYZER; SMART ANESTHESIA MULTI-GAS (SAM) MODULE

Model Number FGGE3000

Device Problems Overheating of Device (1437); Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found no anomalies.Device evaluation is identified that the unit was overheating due to dust build-up around the fan and the readings were out of tolerance confirming the reported event.The dust build-up was removed.The device was calibrated.The front and rear connectors, and housing was checked for damage.The root cause for the reported event is determined to be a result of normal use.This type of event will continue to be monitored.It should be noted that this is being filed based on retrospective review.

Event Description

Reportedly, post repair, the readings were incorrect.There was no report of patient involvement.No additional information is available.

• Brand Name: GE SAM GAS ANALYZER
• Type of Device: SMART ANESTHESIA MULTI-GAS (SAM) MODULE
• Manufacturer (Section D): MARQUETTE ELECTRONICS, INC.; 8200 west tower ave.; milwaukee WI 53223
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9665815
• MDR Text Key: 177837117
• Report Number: 3007409280-2020-00029
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGGE3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• 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