MAUDE Adverse Event Report: MASIMO CORPORATION RAD-97; OXIMETER

Model Number RAD-97

Device Problems Unable to Obtain Readings (1516); Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Pulse oximeter unit turns on, but will not read data.

• Brand Name: RAD-97
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 15515596
• MDR Text Key: 300907531
• Report Number: 15515596
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RAD-97
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1