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

Device Problems Incorrect Measurement (1383); Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Date 09/28/2014

Event Type  malfunction  

Event Description

Massimo hand held oximeter (rad 57) with heart rate and saturations that did not correlate with regular monitor readings prior to transfer from peds to nicu.Intermittent reading in transit and upon arrival to nicu.Ongoing massimo hand held pulse oximeter (rad 57) issues since 2012, cure letter sent on (b)(4) 2014.

• Brand Name: RAD 57
• Type of Device: HAND HELD PULSE OX
• Manufacturer (Section D): MASSIMO; irvine 85008
• MDR Report Key: 4207192
• MDR Text Key: 4978178
• Report Number: MW5038831
• 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
• Patient Age: 20 DA