MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 REGIONAL OXIMETER MODULE

Model Number 24667

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

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.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Device not returned.

Event Description

The customer reported inaccurate o3 readings.No patient impact or consequences were reported.

• Brand Name: O3 REGIONAL OXIMETER MODULE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• 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 92618-1604 ; 9492977168
• MDR Report Key: 8612210
• MDR Text Key: 145126223
• Report Number: 2031172-2019-00246
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• 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: 04/23/2019

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 Model Number: 24667
• Device Catalogue Number: 9637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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
• Treatment: ROOT AND O3 SENSOR