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

Model Number 2319

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

Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.

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 INF-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: 6778949
• MDR Text Key: 82595174
• Report Number: 2031172-2017-00778
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997000885
• UDI-Public: (01)10843997000885(17)191201(10)K16NWY
• 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: 2319
• Device Catalogue Number: 2319
• Device Lot Number: K16NWY
• 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: 12/23/2016
• 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