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

Model Number 4003

Device Problem Sensing Intermittently (1558)

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

Event Date 01/01/2024

Event Type  malfunction  

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.

Event Description

The customer reported the sensor provided solid values on the monitor and then the reading just flatlined for no apparent reason.There was no patient impact or consequence reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned sensor was evaluated.The sensor had no damage or defects during the visual inspection.The sensor passed continuity, and functional testing.During additional testing, there were no intermittent readings observed.The sensor was determined to be functioning as designed.

Event Description

The customer reported the sensor provided solid values on the monitor and then the reading just flatlined for no apparent reason.There was no patient impact or consequence reported.

• Brand Name: RD SET NEO
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 18744242
• MDR Text Key: 336529481
• Report Number: 3019388613-2024-00019
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Device Lot Number: E23JM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1