MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS DC-I; OXIMETER

Model Number	1863
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, 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 a faulty sensor always reads 80 even when not connected to a patient.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation, the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.(b)(6).

• Brand Name: LNCS DC-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7295223
• Report Number: 2031172-2018-00122
• Device Sequence Number: 1249940
• Product Code: DQA
• UDI-Device Identifier: 00843997000406
• UDI-Public: 00843997000406
• 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: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• 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: 1863
• Device Catalogue Number: 1863
• Device Lot Number: 17HBA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/25/2018
• Supplement Report FDA Received Date: 03/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1