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 09/24/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.

Event Description

The customer reported the sensors stop working after 3 to 12 hours much shorter than compared to lnop-sensors they've used before.Loss of signal.After checking the monitor, extension cable, and adapter the sensor is replaced and everything works fine.No patient impact or consequences were reported.

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.Model # updated from "4003" to "4003-9".Lot # updated from "e17dut" to "e17dvt".Field: updated from blank to "4/22/2017".Updated from "the customer reported the sensors stopped working after 3 to 12 hours.Much shorter compared to lnop-sensors they've used before.Loss of signal.After checking the monitor, the extension cable, and adapter, the sensor was replaced and everything works fine.No patient impact or consequences were reported." to "the customer reported: "the sensors stop working after 3 to 12 hours.Much shorter compared to lnop-sensors they've used before.Loss of signal.After checking monitor, extension cable and adapter the sensor is replaced and everything works fine." no patient impact or consequences were reported.".

Event Description

The customer reported: "the sensors stop working after 3 to 12 hours.Much shorter compared to lnop-sensors they've used before.Loss of signal.After checking monitor, extension cable and adapter the sensor is replaced and everything works fine." 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: 6961439
• MDR Text Key: 90628427
• Report Number: 2031172-2017-00969
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: 10843997009598
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4003-9
• Device Catalogue Number: 4003
• Device Lot Number: E17DVT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2017
• 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