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

Model Number	4004-1
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative:multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported the value was came up and off.Clarification was obtained from the customer regarding the report: "the value was received on the monitor and then suddenly display no values." no patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.No physical damage was observed during external visual inspection.The sensor failed continuity testing due to an open infrared in the emitter assembly.The open infrared was most likely due to a failure between bond wire and die attach.When the sensor is connected to a monitoring device the device displays a "replace sensor" error message.(b)(6).

• Brand Name: RD SET NEOPT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6840673
• Report Number: 2031172-2017-00859
• Device Sequence Number: 750795
• Product Code: DQA
• UDI-Device Identifier: 10843997009604
• UDI-Public: 10843997009604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 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 Expiration Date: 10/01/2019
• Device Model Number: 4004-1
• Device Catalogue Number: 4004
• Device Lot Number: 16KYQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/03/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1