MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RC25-4RA EMS, RAINBOW PATIENT CABLE; OXIMETER

Model Number	4485
Medical Device Problem Codes	Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the cable provided "confused values" or an error message.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.No physical damage was observed during visual inspection.During continuity testing with a tester, there was an open in the cable on the green conductor, inside the bend relief area of the m15 connector.Testing with a monitor showed a "sensor off" error message displayed and an audible and visual alarm.The cable is malfunctioning and is unable to perform spo2 and pulse rate simulation tests.
Event or Problem Description
The customer reported that the cable provided "confused values" or an error message.No consequences or impact to patient were reported.

• Brand Name: RC25-4RA EMS, RAINBOW PATIENT CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12100781
• Report Number: 3011353843-2021-00154
• Device Sequence Number: 3820050
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 20CEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1