MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS Y-I; OXIMETER

Model Number	2505
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
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 sensor is working intermittently.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was analyzed.The sensor passed visual inspection, however was unable to pass functional testing due to a failed continuity test.The sensor was found to have broken solder joints on the green and white conductors.When the returned sensor was connected to a masimo device, the device displayed "sensor off patient" and was unable to engage in monitoring.
Event or Problem Description
The customer reported the sensor is working intermittently.No patient impact or consequences were reported.

• Brand Name: M-LNCS Y-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7651205
• Report Number: 2031172-2018-00352
• Device Sequence Number: 1899038
• Product Code: DQA
• UDI-Device Identifier: 00843997003254
• UDI-Public: 00843997003254
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K041815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 2505
• Device Catalogue Number: 2505
• Device Lot Number: 17KQD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1