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

Model Number	2501-7
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.
Event or Problem Description
The customer reported intermittently would display values and then suddenly no values with no error message.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.Eeprom content verification did not identify any issues.The sensor failed visual inspection due to green residue observed at the m15 connector.The residue was most likely from a cleaning solution that did not properly dry out after customer application.The sensor passed continuity testing and no open connections were detected.When the sensor was connected to a masimo monitoring device, the device was able to generate an error message and obtain readings.The customer complaint was not duplicated.Initial reporter zip code exceeded the maximum number of allowable digits, zip code is as follows: (b)(6).Model # updated from "2501" to "2501-7".

• Brand Name: M-LNCS DCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6867804
• Report Number: 2031172-2017-00882
• Device Sequence Number: 1182132
• Product Code: DQA
• UDI-Device Identifier: 00843997003193
• UDI-Public: 00843997003193
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 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: 2501-7
• Device Catalogue Number: 2501
• Device Lot Number: K16MET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1