MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY LNCS DB-I; OXIMETER

Model Number	2653
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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 loses values sporadically.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.No physical damage was observed during visual inspection.The sensor failed continuity testing due to a short betweeen the legs of the detector assembly.When connected to a monitor a "sensor off patient" error message was provided.
Event or Problem Description
The customer reported the sensor loses values sporadically.No patient impact or consequences were reported.

• Brand Name: LNCS DB-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11787347
• Report Number: 3011353843-2021-00110
• Device Sequence Number: 3536020
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/14/2021

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: R21AZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1