MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE PATIENT CABLE; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	23858
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation, the cable was connected to the returned module and a lab root.Connection was successfully established; however, measurement values are intermittent.When the cable was manipulated the device would display intermittent "no sensor connected" and "high impedance detected" error messages.The failure was isolated to the patient cable.The cable was opened for internal inspection and a foreign contaminant was identified on the sensor connector pins, causing intermittent loss of signal from sensor due to poor electrical connectivity.
Event or Problem Description
The customer reported signal cutting in and out.Tracking every 10 minutes.No patient impact or consequences were reported.

• Brand Name: SEDLINE PATIENT CABLE
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7391249
• Report Number: 2031172-2018-00193
• Device Sequence Number: 1055664
• Product Code: MWI
• UDI-Device Identifier: 00843997007955
• UDI-Public: 00843997007955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: 23858
• Device Catalogue Number: 3637
• Device Lot Number: A16M270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1