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

Model Number	24667
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
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.
Event or Problem Description
The customer reported the o3 oximeter is giving low rso2 values.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the o3 oximeter is giving low rso2 values.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.Sensor was able to obtain measurements on each channel at 75% rso2 through 10 minutes of continuous testing; measurements were acceptable when compared to measurements obtained by a known good o3 sensor.Internal inspection revealed contaminant on u2 chip on analog board.The reported issue was not duplicated as the sensor provided accurate readings.However, the contaminant on analog board u2 chip could potentially cause the lower values seen by customer.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.Model # was corrected from 9637 to 24667.

• 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: 8146667
• Report Number: 2031172-2018-00566
• Device Sequence Number: 11423264
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 01/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/27/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1