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

Model Number 4054

Device Problem Sensing Intermittently (1558)

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

Event Date 12/01/2021

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 was in use and stopped working for no reason.No consequences or impact to patient were reported.

Event Description

The customer reported the sensor was in use and stopped working for no reason.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.The sensor passed visual inspection; however it failed continuity testing due to a broken trace inside the connector.An error message displayed on the lab monitor and the sensor led did not illuminate., corrected data: b3 from (b)(6) 1901 to (b)(6) 2021.

• Brand Name: RD SET YI
• 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: 13416204
• MDR Text Key: 285246892
• Report Number: 3019388613-2022-00037
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997013079
• UDI-Public: 00843997013079
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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: Other
• Device Expiration Date: 01/01/2024
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 21APQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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
• Treatment: RD SET DCI