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 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

The returned module was evaluated.The module was connected to a root device and communication was successfully established.Both channels were able to take measurements which were consistent with measurements from a known good o3.After adding humidity to the connector side, the values were inconsistent with measurements from a known good o3.Internal inspection revealed that the cable connector had signs of contamination damages.The o3 module didn't work correctly and showed wrong values due to the contamination damages to the cable connector.Initial reporter phone number exceeded the maximum allowable characters, the phone number is as follows: (b)(6).

Event Description

The customer reported that the module didn't work.The module was returned for evaluation and it was determined that the module had contamination which resulted in inaccurate measurements.No consequences or impact to patient 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: 8553081
• MDR Text Key: 143265386
• Report Number: 2031172-2019-00218
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/26/2019

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 Model Number: 24667
• Device Catalogue Number: 9637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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