MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RC25-4RA EMS, RAINBOW® PATIENT CABLE; OXIMETER

Model Number	4485
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the cable was inaccurate when it is moved.No consequences or impact to patient were reported.
Additional Manufacturer 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 phone # is: (b)(6).Device not returned.
Event or Problem Description
The customer reported the cable was inaccurate when it is moved.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing 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, other text: initial reporter phone # is entered as "(b)(6) " as it exceeded the maximum allowable characters.Initial reported phone # is: (b)(6).

• Brand Name: RC25-4RA EMS, RAINBOW® PATIENT 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 14801491
• Report Number: 3019388613-2022-00140
• Device Sequence Number: 19986742
• Product Code: DQA
• UDI-Device Identifier: 00843997013420
• UDI-Public: 00843997013420
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080238
• 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
• 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: 4485
• Device Catalogue Number: 4485
• Device Lot Number: 20GQY
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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