MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RED LNC-10; OXIMETER

Model Number 2056

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2022

Event Type  Death  

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 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.

• Brand Name: RED LNC-10
• Type of Device: 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
• MDR Text Key: 325060791
• Report Number: 3019388613-2023-00245
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997001267
• UDI-Public: 00843997001267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2056
• Device Catalogue Number: 2056
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death