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

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

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

Event Date 09/18/2014

Event Type  malfunction  

Event Description

When attempting to use the hand held massimo pulse oximeter (rad 57) in the delivery room for resuscitation of a baby the device would not work and would not work/display values.Proper placement and location confirmed without improvement in values.Ongoing issues noted with massimo hand held pulse oximeter since 2012, cure letter sent on (b)(4) 2014.

• Brand Name: RAD 57
• Type of Device: HAND HELD PULSE OXIMETER
• Manufacturer (Section D): MASSIMO; irvine
• MDR Report Key: 4207193
• MDR Text Key: 4964271
• Report Number: MW5038832
• 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