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

Model Number 4053-9

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

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 inaccurate values.Additionally the customer reported failed readings accompanied by an error message.No consequences or impact to patient were reported.

Manufacturer Narrative

The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed., corrected data: d2b procode: was corrected from dqa to dpz.

• Brand Name: RD SET TC-I
• 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: 7288078
• MDR Text Key: 100785550
• Report Number: 2031172-2018-00110
• Device Sequence Number: 1
• Product Code: DPZ
• UDI-Device Identifier: 00843997009904
• UDI-Public: 00843997009904
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4053-9
• Device Catalogue Number: 4053
• Device Lot Number: 17AKM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• 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