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

Model Number	4078
Medical Device Problem Codes	Device Alarm System (1012); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
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.
Event or Problem Description
The customer reported that the cable was not reading any saturation at all and had turned itself off with no alarm to indicate cessation of monitoring.No patient impact or consequences were reported.
Event or Problem Description
The customer reported that the cable was not reading any saturation at all and had turned itself off with no alarm to indicate cessation of monitoring.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.

• Brand Name: RD RAINBOW SET R25-12
• 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: 14806835
• Report Number: 3019388613-2022-00144
• Device Sequence Number: 4960933
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 4078
• Device Catalogue Number: 4078
• Device Lot Number: R18EGS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2018
• 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