MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. INFINITY ETCO2 MICROSTREAM SMARTPOD; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS- PHASE

Model Number 1PX1

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Event Description

During placement of an endotube, it was reported that the endotube carbon dioxide pod was unable to validate endotube placement.Reportedly a hardware malfunction occurred.The pod was removed from service, sent to the manufacturer, and the manufacturer issued a replacement pod.Patient was successfully intubated with no patient harm reported.

• Brand Name: INFINITY ETCO2 MICROSTREAM SMARTPOD
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS- PHASE
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 5899723
• MDR Text Key: 52922541
• Report Number: 5899723
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1PX1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 17