MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY LNCS DB-I; OXIMETER

Model Number	2653
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
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.Other, other text: (b)(6).
Event or Problem Description
The customer reported "intermittent fault." no consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.The sensor pass visual inspection, but failed continuity testing due to an intermittent open in the cable on the detector circuit at the bend relief area of the connector.The sensor functioned intermittently and when the sensor is manipulated to an "open" condition, an error message displayed on the lab testing monitor.Initial reporter zip code exceeded the maximum allowable characters, zip code is (b)(6).Initial reporter phone # is entered as (b)(6) to meet the minimum allowable characters.Initial reporter phone # is (b)(6).
Event or Problem Description
The customer reported "intermittent fault." no consequences or impact to patient were reported.

• Brand Name: LNCS DB-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 9130338
• Report Number: 3011353843-2019-00064
• Device Sequence Number: 11388753
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: 19B15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1