MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MD20 - 12; OXIMETER

Model Number	4104
Medical Device Problem Codes	Sensing Intermittently (1558); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/02/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional manufacturing 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
It was reported that the cable sometimes doesn't work and the measuring device (rad-8) shows the error message "sen off".The patient was being monitored at home with the cable has expired on (b)(6) 2016.
Additional Manufacturer 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.
Additional Manufacturer Narrative
Corrected data updated to include "adverse event;" and "death" and the provided date: "(b)(6) 2016".

• Brand Name: RD SET MD20 - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6158917
• Report Number: 2031172-2016-01400
• Device Sequence Number: 13642890
• Product Code: DQA
• UDI-Device Identifier: 00843997010313
• UDI-Public: (01)00843997010313(11)160801(10)16H5T
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4104
• Device Catalogue Number: 4104
• Device Lot Number: 16H5T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 02/06/2017; 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death