MAUDE Adverse Event Report: MASIMO CORPORATION RD RAINBOW SET R25-12 RD RAINBOW SET SERIES PATIENT CABLE; OXIMETER

Model Number	4078
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Model 4078 - the cable stopped responding with the monitor.It was plugged and unplugged several times.The pulse oximeter (pulse ox) on the patient was tried with another new cable and the pulse ox was then read by the monitor.This was quickly fixed and did not impact the patient for more than a few minutes.Heart rate (hr) on the monitor was reading appropriately during this time.Given to representative.Model 4013 - patient born via c-section.Following delivery, a pulse oximeter used in the neonatal room was applied to patient's right hand.Unable to get an oxygen saturation reading until the hand was physically held by the provider with zero movement.It took approximately 3 minutes following delivery to obtain any saturation reading.According to the provider talked to, this happens at most deliveries and people are "used to it" taking so long to occur.Probe or cable not saved.Model 4478, pulse ox was not reading appropriately.When on patient's foot, it would fail to pick-up any readings.When disconnected and reconnected, it picked up briefly, but did not give an accurate reading (poor photoplethysmograph and pulse reading on pulse oximeter did not correlate with electrocardiogram(ecg) heart rate).Pulse oximeter cable exchanged; problem resolved.Device was saved and returned to masimo representative.

• Brand Name: RD RAINBOW SET R25-12 RD RAINBOW SET SERIES PATIENT CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 17649914
• Report Number: 17649914
• Device Sequence Number: 6332002
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: (01)00843997010665
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 07/11/2023

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 Model Number: 4078
• Device Catalogue Number: 4078
• Device Lot Number: 23CSD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/11/2023