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 02/14/2022

Event Type  malfunction  

Event Description

The customer reported an intermittent sensor.No consequences or impact to patient were reported.

Manufacturer 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 an intermittent sensor.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: two sensors were returned and evaluated.During continuity testing, one sensor was found to have an open in cable on the emitter circuit and the other sensor had an open in cable on the detector circuit at the bend relief.During functional testing an error message was displayed on the lab monitor for both sensors.One sensor led did not illuminate; the other sensor led did illuminate.

• 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: 13778598
• MDR Text Key: 287268329
• Report Number: 3019388613-2022-00066
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 21CZN
• 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: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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