MAUDE Adverse Event Report: COVIDIEN LP NEONATAL-ADULT SPO2 SENSOR; OXIMETER

Model Number MAXN

Device Problems Failure to Power Up (1476); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2020

Event Type  malfunction  

Event Description

Oximeter probe placed on infant to monitor oxygen saturations but light would not turn on and would not record.First one occurred from a lot number of 202300141h.

• Brand Name: NEONATAL-ADULT SPO2 SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10808667
• MDR Text Key: 215309071
• Report Number: 10808667
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXN
• Device Catalogue Number: MAXN
• Device Lot Number: 202440234H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA