MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET SL-12 RD SET TO SPACELABS PATIENT CABLE; OXIMETER

Model Number	4087
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the spo2 probe was reading erroneously high as verified by arterial blood gas.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: per the report source from health canada, the event occurred on august 25, 2021 and the report was submitted to masimo on november 29, 2023.The product used during the reported event is not available to be returned to masimo to allow an investigation to be conducted.If new information is obtained, a follow up report will be submitted.Initial reporter postal code exceeded the maximum allowable characters, postal code is as follows:t5r 4h5 h3 other text : device not returned.
Additional Manufacturer Narrative
This supplemental mdr updates the brand name to rd set sl-12 rd set to spacelabs patient cable to ensure correlation with the gudid database for part 4087.Initial reporter postal code exceeded the maximum allowable characters, postal code is as follows: (b)(6).
Event or Problem Description
The customer reported the spo2 probe was reading erroneously high as verified by arterial blood gas.  there was no patient impact or consequence reported.
Event or Problem Description
The customer reported the spo2 probe was reading erroneously high as verified by arterial blood gas.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
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.

• Brand Name: RD SET SL-12 RD SET TO SPACELABS 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: 18418543
• Report Number: 3019388613-2023-00282
• Device Sequence Number: 6751505
• Product Code: DQA
• UDI-Device Identifier: 00843997010559
• UDI-Public: (01)00843997010559
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 11/29/2023

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: 4087
• Device Catalogue Number: 4087
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 06/11/2024; 07/10/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 06/21/2024; 07/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1859 LNCS ADTX ADHESIVE SENSOR.
• Patient Sex: Unknown