MAUDE Adverse Event Report: MASIMO - 40 PARKER RED DCI-DC3; OXIMETER

Model Number	2053
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer 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: "according to customer, the sensor suddenly stopped working.Tested at (b)(6) with the same result.Not reliable." no consequences or impact to patient were reported.
Event or Problem Description
It was reported: "according to customer, the sensor suddenly stopped working.Tested at infiniti medical with the same result.Not reliable." no consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was found to visually and audibly alarm during alarm conditions.The sensor was placed on the fluke index 2 simulator for 60 minutes and no problem was found.The sensor was able to obtain spo2 (96%) and pulse rate (75 bpm) values throughout the entire 60 minutes of testing.The sensor provided accurate measurement and was determined to be functioning as designed.

• Brand Name: RED DCI-DC3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7962405
• Report Number: 2031172-2018-00506
• Device Sequence Number: 16564422
• Product Code: DQA
• UDI-Device Identifier: 00843997001236
• UDI-Public: 00843997001236
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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: 2053
• Device Catalogue Number: 2053
• Device Lot Number: 17MDZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1