MAUDE Adverse Event Report: MASIMO RAD 57; PULSE OXIMETER

Device Problems False Reading From Device Non-Compliance (1228); Difficult or Delayed Activation (2577)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Massimo hand held pulse oximeter (rad 57) failed to establish an immediate pulse/sat, on a pt that was in critical need for oxygen during procedure.There was a 20 sec delay and inaccurate pulse oximetry reading.Pt had to repeat study.

• Brand Name: RAD 57
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): MASIMO; irvine ; *
• MDR Report Key: 4207186
• MDR Text Key: 4963787
• Report Number: MW5038828
• 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
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR