MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY O3 LARGE SENSOR; OXIMETER

Model Number 3756-9

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed.Other, other text: onsite clinical personnel indicated that the provided results were appropriate for the patient's condition; however, the customer could not be contacted to confirm this information.(b)(6).

Event Description

The customer reported the values of o3 have dropped without explanation.No consequences or impact to patient were reported.

• Brand Name: O3 LARGE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618 ; 9492977168
• MDR Report Key: 9194992
• MDR Text Key: 174865986
• Report Number: 3011353843-2019-00086
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K160526
• 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
• Report Date: 09/26/2019

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 Expiration Date: 08/01/2022
• Device Model Number: 3756-9
• Device Catalogue Number: 3756
• Device Lot Number: 19HDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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
• Patient Age: 59 YR