MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS DCI; OXIMETER

Model Number 2501

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Attempts for the return of the product as well as additional information requests have been made in order to identify the product involved in the reported event.The customer indicated that the product used for this event was discarded and the lot/serial number was not available.If new information is obtained, a follow-up report will be submitted.

Event Description

It was reported that spo2 does not register.Per the customer, the sensor would pick up a reading, but would go away when the patient moves.No information on error messages and/or audible alarm.No known impact or consequence to patient.

• Brand Name: M-LNCS 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6353092
• MDR Text Key: 68145970
• Report Number: 2031172-2017-00241
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 2501
• Device Catalogue Number: 2501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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