MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO-3; OXIMETER

Model Number 2320

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

The returned sensor was evaluated.During inspection, the sensor passed software testing and visual analysis.The sensor failed continuity testing due to broken green and white conductors at the detector solder joint assembly.During testing, the sensor was able to generate audible and visual alarms, and an error message indicating "probe is off the patient." the reported issue was not confirmed.

Event Description

The customer reported the following issue: "if the probe goes bad (we have had a few), there is no alarm, the patient is then hooked up with no sats on the monitor." no consequences or impact to patient were reported.

• Brand Name: LNCS NEO-3
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6778954
• MDR Text Key: 82583582
• Report Number: 2031172-2017-00779
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997000892
• UDI-Public: (01)10843997000892(17)200201(10)K17BJZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2320
• Device Catalogue Number: 2320
• Device Lot Number: K17BJZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1