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

Model Number	2653
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported this will only read intermittently.Customer has already used other cables, but with same result.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.Visual inspection observed no physical damage.Eeprom content verification did not identify any issues and the sensor passed continuity testing.The sensor was found to be functioning as designed.The customer complaint was not duplicated., corrected data: field changed from "blank" to "(b)(6) 2017".

• Brand Name: LNCS DB-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6842205
• Report Number: 2031172-2017-00866
• Device Sequence Number: 19020316
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: KR17C7Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1