MAUDE Adverse Event Report: COVIDIEN FORMERLY NELLCOR PURITAN BENNET INC. SUSTAINABILITY MAX-N; PULSE OXIMETER

Device Problems Break (1069); Low Test Results (2458)

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

Event Date 08/14/2018

Event Type  malfunction  

Event Description

Appropriate oxygen saturation reading could not be obtained on neonate s/p cesarean birth.The probe was changed multiple times to confirm low reading not matching pt's clinical status.With final change in probe, higher oxygen level was noted.Multiple issues have been noted with probes to include stickers covering light sensor, sensitivity in readings, exposed wiring.Stryker.

• Brand Name: SUSTAINABILITY MAX-N
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): COVIDIEN FORMERLY NELLCOR PURITAN BENNET INC.
• MDR Report Key: 7832277
• MDR Text Key: 119023963
• Report Number: MW5079489
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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