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 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

The devices have not been returned to the investigation facility to allow for an analysis to be performed.If the products are received for evaluation or new information is obtained, a follow up report will be submitted.The initial reporter provided multiple event dates; however, could not determine which date of event belongs to which device.Therefore, the date of event was entered as (b)(6) 2021.

Event Description

The customer reported ten (10) sensors either had no light detected, intermittent light, or no trace detected when in use.No patient impact or consequences were reported.

Event Description

The customer reported ten (10) sensors either had no light detected, intermittent light, or no trace detected when in use.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned sensors were evaluated.Visual inspection found no physical damage.The sensors failed continuity testing because of an open in the cable.The sensors failed functional testing with a radical-7 and an error message was displayed.Two (2) of the 10 returned sensors were fully functional.

• 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: 12799901
• MDR Text Key: 284986670
• Report Number: 3019388613-2021-00311
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997013079
• UDI-Public: 00843997013079
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/18/2021

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 Expiration Date: 09/01/2023
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 20J1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• 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