MAUDE Adverse Event Report: COVIDIEN NELLCOR; OXIMETER

Model Number PM1000N

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 07/10/2017

Event Type  malfunction  

Event Description

When the monitor is turned on it does not acknowledge the spo2 probe and gives message "task-1 generated the error pcba version queried response error".However, if you remove the spo2 probe and turn the power on and then plug in the probe everything works fine.This has happened once before on this unit and had happened on another unit as well with no resolution.After getting it back twice with no resolution we asked that it be replaced.Manufacturer response for pulse oximeter, covidien (per site reporter) =they ask that we send it in under warranty.Manufacturer response for pulse oximieter monitor, covidien (per site reporter).We had sent it in under warranty, they first updated the software and sent it back with the same problem.We sent it back and they replaced the main pcb and sent it back to us with the same problem.We then asked that they replace it and they did.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN; 5870 stoneridge drive; suite 6; pleasanton CA 94588
• MDR Report Key: 6750106
• MDR Text Key: 81367191
• Report Number: 6750106
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PM1000N
• Device Catalogue Number: PM1000N
• Other Device ID Number: 10884521182530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2017
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1