MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MD14 - 08; OXIMETER

Model Number 4108-9

Device Problems Disconnection (1171); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

The returned cable was evaluated.During evaluation, the cable passed visual inspection; eeprom contents were verified and no problems were observed through this verification.During continuity testing, the cable failed due to a broken solder joint on the green conductor inside the mini-d connector.When connected to a monitor and a sensor, "sen off" error message displayed.The cable was confirmed to be malfunctioning.

Event Description

The customer reported that the device stopped working during active patient monitoring.The signal dropped out and would not provide a reading.No consequences or impact to patient were reported.

• Brand Name: RD SET MD14 - 08
• 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: 7543579
• MDR Text Key: 109239727
• Report Number: 2031172-2018-00311
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997010856
• UDI-Public: 00843997010856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4108-9
• Device Catalogue Number: 4108
• Device Lot Number: 17FHH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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