MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MP - 05; OXIMETER

Model Number 4082-9

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.When the cable 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.

Event Description

The customer reported cables stopped working.The information was not reading on the screen.No patient impact or consequences were reported.

• Brand Name: RD SET MP - 05
• 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: 7018408
• MDR Text Key: 92629577
• Report Number: 2031172-2017-01007
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997009775
• UDI-Public: 00843997009775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• 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: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4082-9
• Device Catalogue Number: 4082
• Device Lot Number: 17DWV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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