MAUDE Adverse Event Report: MASIMO - 40 PARKER LNC-10 PATIENT CABLE; OXIMETER

Model Number	1814
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
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.
Event or Problem Description
It was reported that the device works intermittently.Per the customer, "the user reports that the spo2 measurement ends during operation.Re-connecting or replacing the intermediate cable with the infinity m540 eliminates the failure.The finger sensor flashes during the failure.This error occurs sporadically on several m540s and also with several intermediate cables." no known impact or consequence to patient.
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.

• Brand Name: LNC-10 PATIENT CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6434497
• Report Number: 2031172-2017-00381
• Device Sequence Number: 602779
• Product Code: DQA
• UDI-Device Identifier: 00843997000512
• UDI-Public: (01)00843997000512(11)160701(10)16HKZ
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• 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: Other
• Device Model Number: 1814
• Device Catalogue Number: 1814
• Device Lot Number: 16HKZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITY M540