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

Model Number	2505-2
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, 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.(b)(6).
Event or Problem Description
The customer reported: "intermittent monitoring." no consequences or impact to patient were reported.
Event or Problem Description
The customer reported: "intermittent monitoring." no consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned sensor was evaluated and passed visual inspection.It failed continuity testing due to an intermittent open in the cable at the detector circuit at the sensor's bend relief end.When the intermittent connection was held in normal operation and then manipulated to "open" (non-functional) condition, the device went into alarm condition (audibly and visually alarmed), readings zeroed out, pleth went flat, and ¿sensor off patient" error message displayed on the lab monitor.Initial reporter telephone number exceeded the maximum allowable characters, telephone number is as follows: (b)(6).

• Brand Name: M-LNCS Y-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9630165
• Report Number: 3011353843-2020-00003
• Device Sequence Number: 2371619
• Product Code: DQA
• UDI-Device Identifier: 00843997003254
• UDI-Public: 00843997003254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041815
• 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): 12/30/2019

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: 05/31/2022
• Device Model Number: 2505-2
• Device Catalogue Number: 2505
• Device Lot Number: 19E3V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1