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

Model Number	4001-9
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the new sensors had a high failure rate out of the box and intermittent failure afterwards, the red light would not light up or would not stay on.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative (if other): the returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was determined to be functioning as designed, corrected data: ( brand name) was updated from "rd set adt adhesive sensor" to "rd set adt", (model #) was updated from "4000" to "4001-9".

• Brand Name: RD SET ADT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6716542
• Report Number: 2031172-2017-00723
• Device Sequence Number: 16384865
• Product Code: DQA
• UDI-Device Identifier: 10843997009574
• UDI-Public: 10843997009574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 4001-9
• Device Catalogue Number: 4000
• Device Lot Number: 16MPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 07/16/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1