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

Model Number	4054
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported the sensor had intermittent problems.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.The device passed visual inspection, no physical damage was observed.The sensor failed continuity tests, due to an open in the cable on the detector circuit at the bend relief area of the sensor end.The sensor was malfunctioning and provided a "sensor off patient" error message.Corrected data: d2: common device name corrected from "oximeter, product code: dpz" to "oximeter, product code: dqa".G5: pma/510(k) corrected from "k080238" to "k180046".
Event or Problem Description
The customer reported the sensor had intermittent problems.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.The device passed visual inspection, no physical damage was observed.The sensor failed continuity tests, due to an open in the cable on the detector circuit at the bend relief area of the sensor end.The sensor was malfunctioning and provided a "sensor off patient" error message.Corrected data: d2: common device name corrected from "oximeter, product code: dpz" to "oximeter, product code: dqa".G5: pma/510(k) corrected from "k080238" to "k180046".
Event or Problem Description
The customer reported the sensor had intermittent problems.No patient impact or consequences were reported.

• Brand Name: RD SET YI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11584731
• Report Number: 3011353843-2021-00073
• Device Sequence Number: 3596944
• Product Code: DQA
• UDI-Device Identifier: 00843997013079
• UDI-Public: 00843997013079
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K180046
• 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): 03/02/2021

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 Expiration Date: 06/01/2022
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 19K2U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1