MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO; OXIMETER

Model Number	2329-9
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2019
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.(b)(6).
Event or Problem Description
The customer reported the oximetry sensor presented intermittent reading.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the oximetry sensor presented intermittent reading.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.Visual inspection upon receiving revealed no external damage.The sensor failed continuity tests, due to a broken solder joint on the red conductor at the emitter solder joint assembly.The sensor functioned intermittently.The sensor was able to obtain spo2 and pulse rate values when the intermittent connection was held in normal operation.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) and ¿replace sensor¿ error message was displayed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6) initial reporter phone # is entered as (b)(6) to meet the maximum allowable characters.Initial reporter phone # is (b)(6).Corrected data: model # was updated from 2329 to 2329-9.

• Brand Name: LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8341950
• Report Number: 2031172-2019-00082
• Device Sequence Number: 16701690
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: 10843997000922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101896
• 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): 01/23/2019

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: 06/01/2021
• Device Model Number: 2329-9
• Device Catalogue Number: 2329
• Device Lot Number: 18FCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1