MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Catalog Number MAXA

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 05/11/2018

Event Type  malfunction  

Event Description

The patients spo2 monitor was alarming that the pulse ox was in the 70s with a good wave.This patient had been on room air for the past 5 days with spo2 ranging from 93 - 100%.A new spo2 sensor was placed on the patient around 1000 because the prior one had fallen off.At 1400 the monitor alarmed spo2 in 70s with a good wave form.The patient was not in respiratory distress and a new sensor was placed.The new sensor read 100% with the same wave form as the faulty one.This is not the first incidence where an spo2 sensor was suspected to be faulty on nccu recently.However, this was the first time we were able to capture the packaging and lot number.Per site reporter: spoke to customer service and put on hold several times, they tried to refer me to tech support.I told them i wanted to report this to product assurance.I also stated that i have had another product on my desk from another report to be sent back.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7552608
• MDR Text Key: 109540426
• Report Number: 7552608
• 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: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: MAXA
• Device Lot Number: 180470269H
• 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: 05/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2018
• 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
• Treatment: BLOOD PRESSURE CUFF; NO OTHER THERAPIES
• Patient Age: 57 YR
• Patient Weight: 96