MAUDE Adverse Event Report: CARLSBAD (700) -RX SPEC, O2 SENSOR, 700/800/980 MAXTEC; NONE

Catalog Number 10097559

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Asr generated.Please ref asr-(b)(4).

Manufacturer Narrative

The defective oxygen sensor that was referenced in this complaint was a failure out of box.A failure out of box is determined during device servicing and is obvious to the person servicing the device.Device servicing is never performed during patient use.This is not considered an mdr reportable event.Covidien reference number: (b)(4).

• Brand Name: SPEC, O2 SENSOR, 700/800/980 MAXTEC
• Type of Device: NONE
• Manufacturer (Section D): CARLSBAD (700) -RX ; 2101 faraday ave; carlsbad CA 92008
• Manufacturer (Section G): CARLSBAD (700) - RX; 2101 faraday ave; carlsbad CA 92008
• Manufacturer Contact: lisa cardenas ; 2101 faraday ave; carlsbad, CA 92008
• MDR Report Key: 4295777
• MDR Text Key: 179547788
• Report Number: 2025525-2014-00116
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: unknown
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

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?: No
• Device Operator: No Information
• Device Catalogue Number: 10097559
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: 12/01/2014
• Supplement Dates FDA Received: 12/03/2014
• Type of Device Usage: N
• Patient Sequence Number: 1