MAUDE Adverse Event Report: COVIDIEN NELLCOR; CARBON DIOXIDE (CO2) DETECTOR

Model Number PEDICAP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pedicap product was not changing color despite correct placement having been confirmed.There is no report of patient harm associated with this event.

• Brand Name: NELLCOR
• Type of Device: CARBON DIOXIDE (CO2) DETECTOR
• Manufacturer (Section D): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc ; MX
• Manufacturer (Section G): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5111883
• MDR Text Key: 27103924
• Report Number: 2936999-2015-00831
• Device Sequence Number: 1
• Product Code: KHS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/01/2015

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: No Information
• Device Model Number: PEDICAP
• Device Catalogue Number: PEDICAP
• Device Lot Number: 140510002X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1