MAUDE Adverse Event Report: MEDTRONIC NELLCOR ; PULSE GENERATOR

Model Number OXMAX N-600

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

Patient Problem Death (1802)

Event Date 03/10/2019

Event Type  Death  

Event Description

Pulse oximeter was attached, but not alarming (no audible sound heard).

• Brand Name: NELLCOR
• Type of Device: PULSE GENERATOR
• Manufacturer (Section D): MEDTRONIC; minneapolis MN
• MDR Report Key: 8455393
• MDR Text Key: 139993237
• Report Number: 8455393
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXMAX N-600
• Device Catalogue Number: MEV-0313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Distributor Facility Aware Date: 03/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 76