MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE EEG SENSOR; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	2479
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
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 that the "nurse couldn't detect r2 and l2, and r1,ct, l2 measurements were not accurate." no consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned sensors were evaluated.Visual inspection confirmed there were no physical damage.During evaluation the units failed continuity testing due to an open trace between the electrodes and the connector.The sensors were found to be defective.The sensors are single-patient use; functionality testing could not be performed since the sensors were returned used.
Event or Problem Description
The customer reported that the "nurse couldn't detect r2 and l2, and r1,ct, l2 measurements were not accurate." no consequences or impact to patient were reported.

• Brand Name: SEDLINE EEG SENSOR
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8396301
• Report Number: 2031172-2019-00110
• Device Sequence Number: 19191629
• Product Code: MWI
• UDI-Device Identifier: 10843997005804
• UDI-Public: 10843997005804
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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 Expiration Date: 12/01/2019
• Device Model Number: 2479
• Device Catalogue Number: 2479
• Device Lot Number: 17D47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1