MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO RAD-57 SIGNAL EXTRACTION PULSE CO-OXIMETER KIT

Model Number RAD-57

Device Problem Component Missing (2306)

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

Event Date 09/01/2022

Event Type  Injury  

Event Description

My wife has a medical condition which requires monitoring of various systems and we ordered a masimo brand rad-57 pulse co-oximeter from (b)(4) to assist in such.When we received the monitor it was missing the reusable sensor which is necessary to have.Even though the vendor web site depicts the reusable sensor attached to the monitor, the packaging list received with the monitor shows it was supposed to include the reusable sensor, a photo received with the monitor again shows it with the reusable sensor and our invoice indicates we ordered the correct item, (b)(4) is indicating the sensor was not included with our purchase.After showing them all the evidence supporting the sensor was supposed to be included they are only offering to accept our return (at our expenses) and provide us credit instead of our money back.We also contacted masimo directly and did not hear back.We are having to cancel a planned trip due to our inability to monitor my wife.Our understanding is the fda has authority over companies who repackage medical equipment which was fda approved and this vendor sending us necessary equipment which cannot be used as advertised should be addressed.Fda safety report id# (b)(4).

• Brand Name: MASIMO RAD-57 SIGNAL EXTRACTION PULSE CO-OXIMETER KIT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 15437920
• MDR Text Key: 300179496
• Report Number: MW5112073
• Device Sequence Number: 1
• 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
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RAD-57
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 77 KG