MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY MASIMOSET LNCS SPO2 PULSE OX ADHESIVE SENSOR; OXIMETER

Model Number	1859
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Masimo has reached out to the customer to request the return of the device.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.Product not returned.
Event or Problem Description
Per medwatch (b)(4), the customer reported that the sensor spo2 [is] not reading, and the ge beside monitor displays ¿faulty probe'.There was no patient impact or consequence reported.

• Brand Name: MASIMOSET LNCS SPO2 PULSE OX 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: 20428841
• Report Number: 3019388613-2024-00122
• Device Sequence Number: 7608827
• Product Code: DQA
• UDI-Device Identifier: 10843997000298
• UDI-Public: (01)10843997000298(17)270101(10)24AM1
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 1859
• Device Lot Number: 24AM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2024
• 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: 82 YR
• Patient Sex: Male