MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY MASIMOSET LNCS INF PULSE OXIMETER ADHESIVE SENSOR

Model Number	2328
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch mw5161123, the customer reported that the "pulse ox kept flashing but would not give a reading".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the customer confirmed the sensor will not been returned to masimo to allow an analysis to be performed.If the sensor is returned for evaluation or new information is obtained, a follow up report will be submitted.

• Brand Name: MASIMOSET LNCS INF PULSE OXIMETER ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEDICAL TECHNOLOGIES (MALAYSIA) SDN BHD; lot 198512, (plo 547-b) jalan keluli 11, zon 12a; kawasan perindustrian pasir gudang 81700 ; MY 81700
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 20893771
• Report Number: 3019388613-2024-00142
• Device Sequence Number: 15396737
• Product Code: DQA
• UDI-Device Identifier: 10843997000915
• UDI-Public: (01)10843997000915(17)270201(10)E24BT3
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2328
• Device Catalogue Number: 2328
• Device Lot Number: E24BT3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 16 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White