MAUDE Adverse Event Report: MASIMO CORPORATION; OXIMETER

Model Number 4078 - 4082 - 4083

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

This report is for multiple events that have occurred related to masimo rd line cable failures primarily with the masimo spo2 cables for philips monitors (4078, 4082, and 4083).The hospital converted to masimo's rd sensor line at the end of june/beginning of july 2020 and immediately problems were reported by staff in the telemetry units (4082) related to cable failures, spo2 drop outs, and signal fall outs.In august of 2020 the adult hospital operating room converted from ge monitoring to philips monitoring (4078).That same month physicians started reporting low spo2 values that did not match actual blood samples or other monitoring values.Masimo was notified that same month and came onsite in september of 2020 to assess both the or and telemetry areas.The specific incidents of low spo2 values have in some cases lead to unnecessary therapy being given to treat the patient before it was recognized that the values were actually incorrect and the cable was replaced.The masimo cable doesn't fail completely or alert the user in any way that it's not working it simply gives an inaccurate reading leading to interventions that could be harmful.Incidents of inaccurate low spo2 have now been reported in more than just the or and include both telemetry and low acuity monitors.We also had one reported instance of the monitor reporting a higher spo2 value than what was accurate when compared with 2 other systems.The rd line spo2 cables for ge monitors used in the women's and children's hospitals have also seen many failures but only one incident is known so far where the spo2 values were showing abnormally low and when replaced with a new cable read 100%.Another institution called us to to ask about the masimo cables and despite us reporting immediately to masimo that we were having issues after the roll out end of june/beginning of july 2020 and said that they were told by masimo that they were unaware of any other institutions having problems.Manufacturer response for rd set cables with philips monitors, (brand not provided) (per site reporter).Masimo came onsite in september of 2020 for a 4 day visit.We heard talk of masimo conducting some other testing as well but we have not seen any other followup or documentation on that.For model 4078 there were no problems found for model 4082 found corrosion on mx40 tele box pins.This however was not an issue with the lncs cables that were used prior to the rd line.For model 4083 no assessment done.We have had 3 incident reports filed since in nov and dec of 2020 that show this issue still continues for us.

• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 11214182
• MDR Text Key: 228175813
• Report Number: 11214182
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4078 - 4082 - 4083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2020
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1