MAUDE Adverse Event Report: MASSIMO RAD 57; HANDHELD PULSE OXIMETER

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/03/2014

Event Type  malfunction  

Event Description

During a resuscitation at 5 minutes of birth.The heart rate read 40 and spo2 was 50.The actual pts heart rate was over 100 bpm.At 6 minutes it read hr 180 and spo2 and 92.Ongoing issues noted with massimo pulse oximetry hand held rad 57 since 2012.Cure letter sent to massimo (b)(4), 2014.

• Brand Name: RAD 57
• Type of Device: HANDHELD PULSE OXIMETER
• Manufacturer (Section D): MASSIMO; irvine 85008
• MDR Report Key: 4207152
• MDR Text Key: 18029468
• Report Number: MW5038825
• 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