MAUDE Adverse Event Report: COVIDIEN EASYCAP II; ADULT END TIDAL CO2 DETECTOR

Model Number EASYCAP II

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample was yellow upon arrival.

Event Description

Covidien recevied a report that this co2 detector color does not change.No patient involved.

Manufacturer Narrative

(b)(4).

• Brand Name: EASYCAP II
• Type of Device: ADULT END TIDAL CO2 DETECTOR
• Manufacturer (Section D): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc 2257 0; MX 22570
• Manufacturer (Section G): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc 2257 0; MX 22570
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4290850
• MDR Text Key: 12820919
• Report Number: 2936999-2014-01026
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• PMA/PMN Number: K894053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2014

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: EASYCAP II
• Device Catalogue Number: EASYCAP II
• Device Lot Number: 122480012X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2012
• 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