MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO PULE OXIMETER

Model Number PN4083

Device Problems Failure to Sense (1559); Communication or Transmission Problem (2896)

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

Event Date 03/20/2022

Event Type  malfunction  

Event Description

This has been reported 7 times by our site.Masimo pulse oximeter cable sequestered from room 8129.Lot# 20dlb.Error message on philips states spo2 no sensor with no reading on monitor.Masimo pulse oximeter cable sequestered from room 8129.Lot# 20kdw.Error message on philips states spo2 sensor off with no read.Cable sequestered and masimo representative notified.Masimo pulse oximeter cable sequestered from room 8143.No lot# present on cable.Error message on philips states spo2 sensor malfunction.Cable sequestered and masimo rep notified.Masimo pulse oximeter cable sequestered from room 8144.Lot# 19gnb.Error message on philips states spo2 sensor off.Masimo representative notified.Masimo pulse oximeter cable sequestered from room 8142.Lot# 20mav.Error message on philips monitor states spo2 searching with no read.Masimo representative notified.Masimo pulse oximeter cable sequestered from room 8131.Lot# 21j01.Error message on philips states spo2 no sensor.Masimo representative notified.Masimo pulse oximeter cable sequestered from room 8131.Lot# 20mav.Error message on philips monitor states ¿spo2 searching¿ with no read.Masimo representative notified.Manufacturer response for pulse oximeter, masimo pule oximeter (per site reporter) representative has been on site and communicating with clinical site.

• Brand Name: MASIMO PULE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 14695104
• MDR Text Key: 294042663
• Report Number: 14695104
• 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: 04/19/2022

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: Other
• Device Model Number: PN4083
• Device Lot Number: 19GNB, 20MAV, 21J01, 20MAV
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other