MAUDE Adverse Event Report: STRYKER MAX NEONATAL / ADULT PULSE OXIMETER SENSOR

Device Problem Low Test Results (2458)

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

Event Date 08/10/2019

Event Type  malfunction  

Event Description

Stryker pulse ox sensor reading false high (98).Double checked with nellcor pulse ox sensor (showing 93) and am abg (po2 50).Fda safety report id# (b)(4).

• Brand Name: STRYKER MAX NEONATAL / ADULT PULSE OXIMETER SENSOR
• Type of Device: OXIMETER
• MDR Report Key: 8906922
• MDR Text Key: 154924315
• Report Number: MW5089126
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 124