MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number 4003

Device Problems Degraded (1153); Incorrect, Inadequate or Imprecise Result or Readings (1535); Sensing Intermittently (1558); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Model number 4003: device 1: screen read "error replace pulse ox cord".The cord was replaced and the device worked after this.Device 2: the pulse oximeter would just randomly go flat line and not have a reading several times throughout the night.Nurse noticed infant oxygen saturations were reading lower than the night prior.Infant was not agitated during these episodes.Tried repositioning the probe.Finally after multiple attempts to fix, the probe was changed out for a new one.It was noted that there were exposed wires.This was the long probe.Model number 4005: device 3: pulse-ox probe spontaneously stopped working and the monitor showed "spo2 sensor malf".Upon viewing the infant, the red light on the probe was not lit up and the infant was quiet in the incubator, not moving the extremity that the probe was on.The probe was unplugged and replugged twice, with no change, and no red light.The probe was switched out for a new one, and the issue was resolved.The patient was without a pulse-ox for approximately 5 minutes.Device 4: had pulse ox from night shift on right foot.Assessed baby and repositioned pulse ox on left foot.Plethysmograph was good at first, but then it stopped for approx.5 minutes.I unplugged and reconnected, repositioned, and changed extremities.Plethysmograph would come up for a minute but then go out again.I got a new pulse ox and that new one worked.Misc.Unknown model number: device 5: patient had long cord pulse oximeter adhesive sensor on when it was noted to not have a reading.I checked the cord connection, repositioned, changed extremity, changed to new sticker and it would still not read.I replaced with a new sensor and it started working, so i didn't change out the cord.Device 6: pulse ox probe was found to have exposed wires during morning assessment.Pulse ox probe was changed and old product was given to nurse supervisor.Device 7: long cord pulse ox could not pick up a reading for 30 minutes.Once the reading was picked up, still not good waveform.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 17097230
• MDR Text Key: 316860447
• Report Number: 17097230
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1