MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-57 PULSE CO-OXIMETER

Model Number	25195
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the spmet values were reading higher than they should.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: the customer mx-51 board did not have the spmet parameter enabled and spmet measurements could not be obtained.G.5.510k was listed as:k080238; is k053477.
Event or Problem Description
The customer reported the spmet values were reading higher than they should.No patient impact or consequences were reported.

• Brand Name: RAD-57 PULSE CO-OXIMETER
• 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: 17401953
• Report Number: 3019388613-2023-00186
• Device Sequence Number: 7357652
• Product Code: DQA
• UDI-Device Identifier: 00843997006163
• UDI-Public: 00843997006163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K053477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 25195
• Device Catalogue Number: 9216
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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