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

Model Number	24667
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8553081
• Report Number: 2031172-2019-00218
• Device Sequence Number: 374014
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1