MAUDE Adverse Event Report: MASSIMO RAD 57; HAND HELD PULSE OXIMETER

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Massimo hand held oximeter (rad 57) did not read reliable during resuscitation with ppv and oxygen.Pt date intermittently on and off while rushing pt to nicu.

• Brand Name: RAD 57
• Type of Device: HAND HELD PULSE OXIMETER
• Manufacturer (Section D): MASSIMO; irvine
• MDR Report Key: 4207175
• MDR Text Key: 4963305
• Report Number: MW5038826
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1