MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET TCI; OXIMETER

Model Number	4053-9
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2019
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 the spo2 value was always 100.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the spo2 value was always 100.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.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).Model# updated from 4053 to 4053-9.

• Brand Name: RD SET TCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 8936155
• Report Number: 3011353843-2019-00044
• Device Sequence Number: 2520735
• Product Code: DQA
• UDI-Device Identifier: 00843997009904
• UDI-Public: 00843997009904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2019

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: 4053-9
• Device Catalogue Number: 4053
• Device Lot Number: 18M03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1