MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY LNCS DB-I; OXIMETER

Model Number	2653
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.Initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).Device not returned.
Event or Problem Description
The customer reported the device no longer "conducts" after a short time in operation.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.No physical damage was observed during visual inspection.The device failed continuity testing, broken wire at emitter solder joint assembly.The device failed functionality testing using a lab monitor and a "replace sensor" error message was displayed.Sensor led does not illuminate.Initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).
Event or Problem Description
The customer reported the device no longer "conducts" after a short time in operation.No patient impact or consequences were reported.

• Brand Name: LNCS DB-I
• Common Device Name: 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: 14961688
• Report Number: 3019388613-2022-00155
• Device Sequence Number: 5395392
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: 21AHF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown