MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER MAX-N PULSE OXIMETER SENSOR; PULSE OX SENSOR

Model Number TD11852 REV A

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Event Description

When removing pulse oximetry cord from infant, the adherent, fan bandage piece pulled apart exposing wires and materials used for monitoring.This was being removed from infant because it was not working and it was being replaced.No waveform was ever obtained while attempting use.No mark on infant or injury noted.A new pulse oximetry was placed on and worked appropriately.

• Brand Name: STRYKER MAX-N PULSE OXIMETER SENSOR
• Type of Device: PULSE OX SENSOR
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 7406280
• MDR Text Key: 104873099
• Report Number: MW5076369
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TD11852 REV A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3