MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD RAINBOW SET¿ R25-12 RD RAINBOW SET CABLE; OXIMETER

Model Number	4078
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cables were evaluated.The cable (lot 24dap) passed all visual and functional testing.Visual inspection of the concomitant cable (lot 23nta) showed some residue on and around pogo pins.Both cables were able to obtain spo2 and pulse rate readings.The cables were functioning electrically as designed.
Event or Problem Description
The customer reported that the cable caused a "sensor malfunction" error to display on the host monitor.There was no patient impact or consequence reported.

• Brand Name: RD RAINBOW SET¿ R25-12 RD RAINBOW SET 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: 20782581
• Report Number: 3019388613-2024-00138
• Device Sequence Number: 12013330
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: (01)00843997010665(11)240405(10)24DAP
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 4078
• Device Lot Number: 24DAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• 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: RD RAINBOW SET R25-12, PATIENT CABLE LOT NO 23NTA
• Patient Sex: Unknown