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

Model Number 4050-9

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.During inspection, the sensor passed visual analysis and software testing; however failed functional analysis due to multiple broken traces inside the rd15 connector; causing multiple open connections.A ¿no sensor connected" error message displayed; which would have prevented the unit from being able to engage in monitoring activities.(b)(6).

Event Description

It was reported that "spo2 cables stopped worked".No known impact or consequence to patient was reported.

• Brand Name: RD SET DCI
• 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: 6596247
• MDR Text Key: 76151296
• Report Number: 2031172-2017-00617
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)160901(10)E16JPR
• 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: health professional,user faci
• Reporter Occupation: Health 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: 05/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4050-9
• Device Catalogue Number: 4050
• Device Lot Number: E16JPR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1