MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO CS-3; OXIMETER

Model Number 4478

Device Problems Break (1069); Incorrect Measurement (1383); Sensing Intermittently (1558)

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

Event Date 09/24/2022

Event Type  malfunction  

Event Description

The customer reported via the medwatch exposed wires, wire being hot, shutting off unexpectedly, difficulty picking up saturations and unreliable saturation rates.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.

• Brand Name: RD SET NEO CS-3
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16443587
• MDR Text Key: 310430159
• Report Number: 3019388613-2023-00042
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2023

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 Operator: Health Professional
• Device Model Number: 4478
• Device Catalogue Number: 4478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RD SET INF CS-3