MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RED DCI-DC12; OXIMETER

Model Number	2054
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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.
Event or Problem Description
The customer reported the sensor stops working suddenly.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no damage.The sensor failed continuity testing due to an open in the cable on the detector circuit along the length of the cable.When connected to a monitor a "sensor off patient" error message was provided.
Event or Problem Description
The customer reported the sensor stops working suddenly.No patient impact or consequences were reported.

• Brand Name: RED DCI-DC12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11826312
• Report Number: 3011353843-2021-00117
• Device Sequence Number: 4015574
• Product Code: DQA
• UDI-Device Identifier: 00843997001243
• UDI-Public: 00843997001243
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Model Number: 2054
• Device Catalogue Number: 2054
• Device Lot Number: 20G2T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1