MAUDE Adverse Event Report: MEDTRONIC NELLCOR; PULSE OXIMETRY

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/31/2016

Event Type  malfunction  

Event Description

Pulse oximetry not sense pulse/o2 during motion of baby.

• Brand Name: NELLCOR
• Type of Device: PULSE OXIMETRY
• Manufacturer (Section D): MEDTRONIC; 710 medtronic pkwy.; minneapolis MN 55432
• MDR Report Key: 6633283
• MDR Text Key: 77314161
• Report Number: 6633283
• Device Sequence Number: 1
• Product Code: DQA
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2017
• 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