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

Model Number	2329
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Sensing Intermittently (1558); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2021
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 glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the sensor glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned sensors were evaluated.Visual inspection found sliding neck tape at sensor end; causing exposed conductor jackets and shields.Visual inspection on another returned sensor found no physical damage.During continuity tests; no short or open was detected, and no intermittent short or open was detected when manipulated.The devices are functioning electrically as designed.The sensors were tested with a lab cable for 15 minutes continuously and no problem was found, able to obtain spo2 and pulse rate values throughout the entire 15 minutes of testing.

• Brand Name: LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11387106
• Report Number: 3011353843-2021-00052
• Device Sequence Number: 19855774
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: 10843997000922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 02/01/2023
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Device Lot Number: 20B2Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1