MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number 2016793-003

Device Problems Erratic or Intermittent Display (1182); Unable to Obtain Readings (1516); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

At approximately 2313 cardiac monitor went blank then came back on and all setting reset, and trends were missing from patient's admit time to 2314.Unable to retrieve important vs up to 2314 when monitor restarted.

• Brand Name: MASIMO
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 11398737
• MDR Text Key: 234248352
• Report Number: 11398737
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2016793-003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA