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

Model Number 4000

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the product used during the reported event has been discarded; and therefore, could not be returned to masimo for evaluation in the event that the involved product is received and an evaluation completed, or if new information is obtained, a follow up report will be submitted.

Event Description

The customer reported intermittent readings, lengthy measuring times, and when a reading comes up it is typically a much lower number than what the clinician expects no consequences or impact to patient were reported.

• Brand Name: RD SET ADT
• 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6337747
• MDR Text Key: 67649572
• Report Number: 2031172-2017-00217
• Device Sequence Number: 1
• Product Code: DQA
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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