MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS INF-L; OXIMETER

Model Number	1861-1
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
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 a problem with the durability of disposable sensors.Some sensors stopping measurement after some hours, some after one day.Monitor shows no curve (0-line) and no values.No patient impact or consequences reported.

• Brand Name: LNCS INF-L
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6352514
• Report Number: 2031172-2017-00237
• Device Sequence Number: 11023491
• Product Code: DQA
• UDI-Device Identifier: 10843997000304
• UDI-Public: (01)10843997000304(17)191201(10)K16NXX
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

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: 1861-1
• Device Catalogue Number: 1861
• Device Lot Number: K16NXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1