MAUDE Adverse Event Report: MASIMO CORPORATION MIGHTYSAT; OXIMETER

Model Number 9707-1

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

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

Event Date 08/07/2016

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.

Event Description

It was reported that the device battery consumption is fast.The measured values (spo2, hr) are low.No known impact or consequence to patient.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was determined to be functioning as designed.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows (b)(4).

• Brand Name: MIGHTYSAT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 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: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 5921621
• MDR Text Key: 53724845
• Report Number: 2031172-2016-00966
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9707-1
• Device Catalogue Number: 9707-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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