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

Model Number	24667
Medical Device Problem Codes	Incorrect Measurement (1383); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.Device not returned.
Event or Problem Description
The customer reported when the o3 module is connected and in use the readings are dropping out and intermittent.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection revealed contamination damage to the connectors.Both channels were able to obtain measurements.Channel 1 measurements were intermittent and inconsistent with measurements from a known good o3 module, and channel 2 measurements were consistent with measurements from a known good o3 module.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event.
Event or Problem Description
The customer reported when the o3 module is connected and in use the readings are dropping out and intermittent.No patient impact or consequences 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: 8620038
• Report Number: 2031172-2019-00252
• Device Sequence Number: 245188
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 05/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1