MAUDE Adverse Event Report: GE HEALTHCARE E-SCAIO; ANALYZER, GAS, OXYGEN, GASEOUS

Model Number E-SCAIO-00

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 07/21/2018

Event Type  malfunction  

Event Description

Etco2 reader displayed error message, machine would not pick up etco2 or et for inhalation agent.Machine had passed check before case.Also, daily check.

• Brand Name: E-SCAIO
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS
• Manufacturer (Section D): GE HEALTHCARE; wauwatosa WI 53226
• MDR Report Key: 7752551
• MDR Text Key: 116293356
• Report Number: MW5078877
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2018

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: E-SCAIO-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR