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

Model Number	2320
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7043521
• Report Number: 2031172-2017-01021
• Device Sequence Number: 13928539
• Product Code: DQA
• UDI-Device Identifier: 10843997000892
• UDI-Public: 10843997000892
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K094046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: USER REPORT MW5072658.
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other