MAUDE Adverse Event Report: COVIDIEN LP NELLCOR PEDIATRIC COLORIMETRIC CO2 DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number PEDICAP 6

Device Problem Material Integrity Problem (2978)

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

Event Date 10/02/2022

Event Type  malfunction  

Event Description

Intubation of term infant with use of pediatric colorimetric co2 detector use to confirm intubation.One pedicap had zero color change, the next pedicap had color change for 10 breaths and then returned to purple.Patient had good chest rise, bilateral breath sounds and increasing oxygen saturations indicating a successful intubation.

• Brand Name: NELLCOR PEDIATRIC COLORIMETRIC CO2 DETECTOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15635746
• MDR Text Key: 302058057
• Report Number: 15635746
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PEDICAP 6
• Device Catalogue Number: PEDICAP 6
• Device Lot Number: 221010073, 221010070
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Weight: 4 KG