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

Model Number 2320

Device Problem Material Separation (1562)

Patient Problem Skin Tears (2516)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

The returned sensor was evaluated.The sensor failed external visual inspection, sliding neck tape at the sensor end caused exposed wire jackets and inner shield.The sensor passed continuity and functional testing.The wire jackets are exposed and not the wire itself, exposed jackets and inner shield do not carry any electrical current.

Event Description

The customer reported a masimo lncs neo-3 spo2 pulse oximeter adhesive sensor from the nicu at iu north that was on a patient, the staff removed it from the patient when they noted minor harm due to the sensor having exposed wires.

• 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: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 7043521
• MDR Text Key: 93127800
• Report Number: 2031172-2017-01021
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997000892
• UDI-Public: 10843997000892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2019
• Device Model Number: 2320
• Device Catalogue Number: 2320
• Device Lot Number: K16HAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: USER REPORT MW5072658.
• Patient Sequence Number: 1
• Patient Outcome(s): Other