MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-67 SPOT CHECK PULSE CO-OXIMETER

Model Number	27692
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported inaccurate high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.
Additional Manufacturer Narrative
Additional manufacturing 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 manufacuring narrative: other, other text: the monitor involved in this case was not returned for evaluation.The involved sensor was returned and evaluated.During evaluation the sensor passed all visual and functional testing.The sensor passed continuity testing using a tester and also passed accuracy tests.The customer's complaint regarding accuracy was not duplicated.Additional information: h6 event problem and evaluation codes, h10 additional manufacturer narrative h3 other text : device not returned.
Event or Problem Description
The customer reported inaccurate high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.
Additional Manufacturer Narrative
Additional manufacuring 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.
Event or Problem Description
The customer reported inaccurate high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.

• Brand Name: RAD-67 SPOT CHECK 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: 15214264
• Report Number: 3019388613-2022-00182
• Device Sequence Number: 4800237
• Product Code: DQA
• UDI-Device Identifier: 00843997012812
• UDI-Public: 00843997012812
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27692
• Device Catalogue Number: 9794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 09/15/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/14/2022; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: DCI-MINI SC 400 SENSOR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White