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

Model Number	4053-9
Medical Device Problem Codes	Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
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.
Event or Problem Description
The customer reported inaccurate values.Additionally the customer reported failed readings accompanied by an error message.No consequences or impact to patient 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., corrected data: d2b procode: was corrected from dqa to dpz.

• Brand Name: RD SET TC-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7288078
• Report Number: 2031172-2018-00110
• Device Sequence Number: 13480928
• Product Code: DPZ
• UDI-Device Identifier: 00843997009904
• UDI-Public: 00843997009904
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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

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: 17AKM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1