MAUDE Adverse Event Report: MASIMO RAD 87; PULSE OXIMETER

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem High Oxygen Saturation (2478)

Event Date 10/22/2014

Event Type  Injury  

Event Description

Sudden/non-clinically evident oximeter values on ge monitor.Values dynamic from 44 for 2 seconds then show 94% without clinical correlation.Values return to >90% in the next immediate 1-2 seconds without gradual rise.During the event, oximetry equipment was being evaluated by oximeter company reps and 3 rn's.Oximeter site + probe + placement + connections + infant status verified by the lead company representative witnessing the equipment malfunction; including the 3 rn's + company oximeter reps at bedside.Company reps notified by rn that oximeter reading behavior is not normative or correlative with the patient's condition.

• Brand Name: RAD 87
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): MASIMO; irvine CA 92618
• MDR Report Key: 4278582
• MDR Text Key: 18732223
• Report Number: MW5039243
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 1 DA