MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET R25-12; OXIMETER

Model Number	4078-9
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.
Event or Problem Description
The customer reported: "was told by rn (b)(6) that the monitor in room 448 sporadically loses the spo2 reading.She changed cables twice during her shift to get it to work.I have the 2 cables from the specific room but not any sensors.As tasked by leadership, i am to pull the cable and send it for failure analysis.Unfortunately the rn did not save the sensor.Logs were pulled and i didn't see any dropouts, just large desats." no patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET R25-12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7170906
• Report Number: 2031172-2018-00008
• Device Sequence Number: 18862689
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial

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: 4078-9
• Device Catalogue Number: 4078
• Device Lot Number: 17H86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70