MAUDE Adverse Event Report: COVIDIEN RESPIRATORY & MONITORING SOLUTIONS MICROSTREAM SMART CAPNOLINE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number 010582

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/20/2017

Event Type  malfunction  

Event Description

Patient in ed being prepared for cardioversion & sedation.Respiratory therapist removed home cannula and placed hospital c02 detecting cannula at same 02 flow of 2l.Patient promptly started dropping 02 sats despite increasing 02 flow.Placed patient on mask & sats rose immediately back to 100%.After cardioversion, patient placed back on a regular cannula at 2l and maintained sats at 100%.Worried that cannula nares may be plugged/occluded.

• Brand Name: MICROSTREAM SMART CAPNOLINE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN RESPIRATORY & MONITORING SOLUTIONS; 5870 stoneridge drive, suite 6; pleasanton CA 94588
• MDR Report Key: 7062865
• MDR Text Key: 93091659
• Report Number: 7062865
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 010582
• Device Lot Number: Q160731495
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 12