MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY MASIMOSET LNCS NEO ADULT ADHESIVE SENSOR; OXIMETER

Model Number	2329
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: through follow up, the customer indicated that the product in use when the reported issue occurred was discarded.If new information is obtained, a follow-up report will be submitted.
Event or Problem Description
Per medwatch report: "pulse ox not working.Cable switched out to isolate what was causing the issue and the pulse ox still would not function.Tried several probes from the same lot number and they would not work.Found a different lot number and they worked.Also found another box with the same lot number as the ones that would not work and they worked".There was no patient impact or consequence reported.

• Brand Name: MASIMOSET LNCS NEO ADULT 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: 19802214
• Report Number: 3019388613-2024-00095
• Device Sequence Number: 7524687
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: (01)10843997000922(17)270401(10)24DU7
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/26/2024

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: 2329
• Device Catalogue Number: 2329
• Device Lot Number: 24DU7
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2024
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic