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

Model Number 4003-9

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.When the sensor was connected to a masimo monitoring device, the device was able to generate an error message.The unit was determined to be functioning as designed.(b)(6).

Event Description

The customer reported: "sensor not working properly.During a resuscitation it took 8 minutes and 3 different sensors before an accurate saturation was picked up.This is not the first time that a sensor of this type has been defective and not worked during a crucial emergency situation." no patient impact or consequences were reported.

• Brand Name: RD SET NEO
• 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: 7064050
• MDR Text Key: 93590761
• Report Number: 2031172-2017-01043
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: 10843997009598
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: 4003-9
• Device Catalogue Number: 4003
• Device Lot Number: E17C5E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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
• Patient Age: 7 HR