MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY MASIMOSET RED LNC-10 LNCS PATIENT CABLE; OXIMETER

Model Number	2056
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional manufacturing narrative: other text: masimo obtained the report information through the maude database.Per communication with the mdr team, "these reports are from our backlog of 21 cfr 803.22(b)(2) notifications before july 2023.The fda does not plan to issue acknowledgement letters to firms who submitted the 803.22 reports or to a firm who is the manufacturer of the subject device prior to the july 2023 date." no additional details are available at this time.H3 other text: device not returned.
Event or Problem Description
Per the maude database- ge healthcare became aware of a patient death which involved another manufacturer's product.A masimo sp02 cable was identified as having been involved with a patient death in 2022.
Additional Manufacturer Narrative
Masimo obtained the report information through the maude database.Per communication with the mdr team, "these reports are from our backlog of 21 cfr 803.22(b)(2) notifications before july 2023.The fda does not plan to issue acknowledgement letters to firms who submitted the 803.22 reports or to a firm who is the manufacturer of the subject device prior to the july 2023 date." no device lot number was included in the maude data therefore no updates are able to be provided to supplement this information including the date of manufacture.No additional details are available at this time.This supplemental mdr updates the brand name to masimoset red lnc-10 lncs® patient cable to ensure correlation with the gudid database.
Event or Problem Description
Per the maude database- ge healthcare became aware of a patient death which involved another manufacturer's product.  a masimo spo2 cable was identified as having been involved with a patient death in 2022.
Additional Manufacturer Narrative
Other, other text: udi related data quality updates only.This correction updates the udi number to include the di and pi fields, all numbers, letters, parentheses, and symbols.As the lot number information was not available for the cable, only the device identifier (01) portion of the udi is provided in this follow-up mdr.As a result, the production identifiers pertaining to manufacturing/production date (11) and batch/lot number (10) could not be included in the udi.H3 other text : product not returned.
Event or Problem Description
Per the maude database - ge healthcare became aware of a patient death which involved another manufacturer's product.A masimo spo2 cable was identified as having been involved with a patient death in 2022.

• Brand Name: MASIMOSET RED LNC-10 LNCS PATIENT CABLE
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17882816
• Report Number: 3019388613-2023-00245
• Device Sequence Number: 15306315
• Product Code: DQA
• UDI-Device Identifier: 00843997001267
• UDI-Public: (01)00843997001267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2056
• Device Catalogue Number: 2056
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024; 07/10/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 06/24/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown