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

Model Number	4083
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2016
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
The customer reported cable works intermittently.No known impact or consequence to patient was reported.
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.Corrected data: date of this report was incorrect in the initial report ((b)(6) 2017).This follow-up report is to correct the date of this report field f/u-001 from "(b)(6) 2017" to "(b)(6) 2017." date received by manufacturer was incorrect in the initial report (07/01/2017).This follow-up report is to correct the date received by manufacturer field f/u-001 from "06/01/2017" to "06/23/2017".

• Brand Name: RD SET MP - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6683059
• Report Number: 2031172-2017-00685
• Device Sequence Number: 211256
• Product Code: DQA
• UDI-Device Identifier: 00843997009782
• UDI-Public: 00843997009782
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050252
• 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 Model Number: 4083
• Device Catalogue Number: 4083
• Device Lot Number: 16KHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1