MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO SET PULSE OXIMETER

Model Number RAD-97

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2021

Event Type  Death  

Event Description

Pulse oximeter functional, displaying reading at 6 pm.The pulse oximeter had been observed to be functioning and displaying readings within normal limits for the pt.At or around 9:20 pm, the device screen was reported to be "lit" but was not displaying numerical readings.Within mins of the finding, the resident was observed to be non-responsive with medical services provided.Ems arrived and attempted to revive the pt without success.The resident expired.Per interview with staff, it could not be determined as to cause of "altoed" function of the device.The device was taken out of service immediately.

• Brand Name: MASIMO SET PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 12681936
• MDR Text Key: 277913383
• Report Number: MW5104866
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAD-97
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 3 YR
• Patient Weight: 17