MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY LNCS TF-I; OXIMETER

Model Number	1896
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.(b)(6).
Event or Problem Description
The customer reported that the device provided high readings.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported that the device provided high readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and continuity testing.The sensor passed spo2 comparison tests against a lab reusable finger clip sensor.The sensor was determined to be functioning as designed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

• Brand Name: LNCS TF-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 8936635
• Report Number: 3011353843-2019-00045
• Device Sequence Number: 713131
• Product Code: DQA
• UDI-Device Identifier: 00843997000055
• UDI-Public: 00843997000055
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 1896
• Device Catalogue Number: 1896
• Device Lot Number: 18GNR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1