MAUDE Adverse Event Report: MASIMO CORPORATION RD SET NEONATE; OXIMETER

Model Number 4003

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/09/2022

Event Type  Injury  

Event Description

My wife gave birth to twins at 29 weeks, 1 day gestational age on (b)(6) 2022 at our local hospital, (b)(6).The twins were in the nicu for 64 days at (b)(6), during which time the nicu used masimo rd set neo pulse oximeters.The pulse oximeters constantly gave false and incorrect readings, often drifting a larger number of absolute percentage points (for example at 95% one sec, then drift to 65% two seconds later, and then to 85%).The only consistency with these products was that they were inconsistent.The result was the pulse oximeter causing alarms, requiring a nurse to attend the twins.In many cases, instead of changing these disposable products every 24-48 hours, nursing staff would be changing the pulse oximeter 5-6 times a day, in the hope to get one that would work for an extended period of time.We raised this issue to hospital staff, and have had discussions with hospital leadership, who confirmed that they switched over to the masimo line of rd set pulse oximeters weeks before our arrival.The nursing staff and doctors confirmed the issues with the products.The situation is a dangerous situation in a setting like a nicu when medical decisions are being made based on oxygen vitals.Hospital leadership also called in representatives from the company who made false claims about the product and never could solve the issue.My wife and i were told that we were "too sensitive to the issue because we had been in the hospital too long".On an average day in the nicu with our twins, the pulse oximeters were giving false and incorrect readings on more than half of the day.I also have video evidence of the issue, where the estimate would drift while the patient was showing to signs or symptoms of desaturation.Upon leaving the nicu, the twins have been healthy, but have had to be readmitted to the nicu once and taken to the er three times due to respiratory viruses.The 3 er visits were at (b)(6) pediatric er, where they also used the masimo rd set, and the same issues were present.Their second nicu stay was at (b)(6) hospital nicu, who used a nelcor pulse oximeter system, and no issues were present during their 9 and 11 day stays at (b)(6).It is imperative that fda look into this problem and likely issue a recall for this product.The masimo pulse oximeters are dangerous, require nursing staff to spread themselves thin across multiple patients having the same issue with the pulse oximeter, and at some point, will kill or injure a neonate or other child.The masino representative that we dealt with one two occasions in two separate departments at (b)(6) were abrasive and unhelpful, providing no solution to the problem.Fda safety report id #(b)(4).

• Brand Name: RD SET NEONATE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 15680322
• MDR Text Key: 302604377
• Report Number: MW5112895
• Device Sequence Number: 3
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/25/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4003
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White