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

Model Number	2508-9
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.(b)(6).
Event or Problem Description
The customer reported the led was blinked, however the values has been displayed on the monitor intermittently.The value has become to be displayed normally as known products once the sensor replaced.This event has been occurred within 1 minute from they wrapped the sensor around the patient's finger, and no patient impact.At that time, they were about to start the monitoring of the patient.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).Corrected data: exp date corrected to 02/01/2020.

• Brand Name: M-LNCS ADTX
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6819660
• Report Number: 2031172-2017-00821
• Device Sequence Number: 44824
• Product Code: DQA
• UDI-Device Identifier: 10843997002506
• UDI-Public: 10843997002506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• 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 Expiration Date: 02/01/2020
• Device Model Number: 2508-9
• Device Catalogue Number: 2508
• Device Lot Number: K17BGZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 08/25/2017
• 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