MAUDE Adverse Event Report: MASIMO CORPORATION RD SET¿ NEO SPO2, PR, PI, PVI® NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR

Model Number 4003

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Pulse ox not working repeatedly throughout my shift despite being new (replaced this morning after a bath only a few hours prior).It was plugged in, patient not moving (asleep), and red light functional.I repeatedly unplugged and re-plugged the pulse ox into the cord, changed locations, replaced the already new pulse ox, and eventually replaced the cord going into the x2 before it finally picked up consistently for several hours.The pulse ox was probably not picking up for 45-60 minutes total between intermittently turning off and troubleshooting multiple times throughout this shift.This is a consistent battle with this product and as such, many staff choose to do the workarounds and may not voice concerns over non-functional pulse ox equipment.This same situation happens a lot for our patients and it has become so common place that most staff don¿t even think about having to randomly unplug and plug them back in repeatedly throughout the shift.An impromptu poll of coworkers says this happens to them too.

Event Description

Pulse ox not working repeatedly throughout my shift despite being new (replaced this morning after a bath only a few hours prior).It was plugged in, patient not moving (asleep), and red light functional.I repeatedly unplugged and re-plugged the pulse ox into the cord, changed locations, replaced the already new pulse ox, and eventually replaced the cord going into the x2 before it finally picked up consistently for several hours.The pulse ox was probably not picking up for 45-60 minutes total between intermittently turning off and troubleshooting multiple times throughout this shift.This is a consistent battle with this product and as such, many staff choose to do the workarounds and may not voice concerns over non-functional pulse ox equipment.This same situation happens a lot for our patients and it has become so common place that most staff don¿t even think about having to randomly unplug and plug them back in repeatedly throughout the shift.An impromptu poll of coworkers says this happens to them too.

• Brand Name: RD SET¿ NEO SPO2, PR, PI, PVI® NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery,; irvine CA 92618
• MDR Report Key: 13558929
• MDR Text Key: 285818705
• Report Number: 13558929
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 11/29/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA
• Patient Sex: Male
• Patient Weight: 6 KG