MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD RAINBOW SET MD20-12; OXIMETER

Model Number	4073
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported spo2 variance found during testing on a preterm infant patient and reported the spo2 readings were fluctuating below the expected spo2 readings.No consequences or impact to patient were reported.
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.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported spo2 variance found during testing on a preterm infant patient and reported the spo2 readings were fluctuating below the expected spo2 readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.During simulation testing, the cable passed manual and preset conditions and provided accurate measurements.  the cable was determined to be functioning as designed., other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: m5g 1x8.

• Brand Name: RD RAINBOW SET MD20-12
• 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: 15136142
• Report Number: 3019388613-2022-00170
• Device Sequence Number: 5197000
• Product Code: DQA
• UDI-Device Identifier: 00843997009744
• UDI-Public: 00843997009744
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/08/2022

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: 4073
• Device Catalogue Number: 4073
• Device Lot Number: 22DFV
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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: Female
• Patient Weight: 2 KG
• Patient Race: White