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

Model Number	23858
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.(b)(6).
Event or Problem Description
The customer reported intermittent readings.No consequences or impact to patient was reported.
Event or Problem Description
The customer reported intermittent readings.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).(model #) was updated from "3637" to "23858".Occupation was updated from "nurse" to "administrator/supervisor".Device mfr date was updated from "02/26/2018" to "02/11/2017".

• Brand Name: RD 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: 7729306
• Report Number: 2031172-2018-00399
• Device Sequence Number: 11029127
• Product Code: MWI
• UDI-Device Identifier: 00843997007955
• UDI-Public: 00843997007955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: A17B087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1