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

Model Number	1895
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2019
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.
Event or Problem Description
The customer reported the device provided inaccurate spo2 values.The expected value was 94 and the monitor showed 74.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the device provided inaccurate spo2 values.The expected value was 94 and the monitor showed 74.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.External visual inspection showed no damage.The sensor failed continuity testing due to low voltage on the red diode.The sensor is functioning but not accurate, it is able to obtain readings but spo2 values are inaccurate when compared to a lab sensor.The low voltage on the red diode is causing the spo2 values to fluctuate rapidly, no problem found with pulse rate measurements.

• Brand Name: LNCS TC-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8308621
• Report Number: 2031172-2019-00060
• Device Sequence Number: 16217748
• Product Code: DQA
• UDI-Device Identifier: 00843997000048
• UDI-Public: 00843997000048
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2019

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: 1895
• Device Catalogue Number: 1895
• Device Lot Number: 18ENJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1