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 Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
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 that the sensors suddenly stopped working.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated and passed visual inspection since no physical damage was observed.The unit failed continuity tests due to a short in cable between the detector circuit and inner shield, along the length of the cable.The sensor is malfunctioning and a ¿sensor off patient" error message displayed on the lab monitor.
Event or Problem Description
The customer reported that the sensors suddenly stopped working.No consequences or impact to patient 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: 11417894
• Report Number: 3011353843-2021-00057
• Device Sequence Number: 14463197
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 19JVL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1