MAUDE Adverse Event Report: MASIMO RAD 57; PULSE OXIMETER

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 10/18/2014

Event Type  malfunction  

Event Description

Hand-held massimo oximeter did not register a valid heart rate or saturation during a resuscitative event after a stat c-section.

• Brand Name: RAD 57
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): MASIMO; irvine ; *
• MDR Report Key: 4206901
• MDR Text Key: 16000256
• Report Number: MW5038808
• Device Sequence Number: 1
• Product Code: DQA
• 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: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1