MAUDE Adverse Event Report: MASIMO - 40 PARKER RC-4 CABLE; OXIMETER

Model Number	2406
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.(b)(6).
Event or Problem Description
The customer reported the cable intermittently would display values then suddenly display no values with no error message.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation, the cable passed visual inspection; eeprom contents were verified and no problems were observed through this verification.However, it failed functional analysis due to open in cable on the white conductor along the length of the cable.A ¿sensor off patient" error message displayed; which would have prevented the unit from being able to engage in monitoring activities.Initial reporter zip code exceeded the minimum allowable digits, zip code is as follows: (b)(6).(labeled for single use?) updated from "yes" to "no".

• Brand Name: RC-4 CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6731060
• Report Number: 2031172-2017-00730
• Device Sequence Number: 16454773
• Product Code: DQA
• UDI-Device Identifier: 00843997002295
• UDI-Public: 00843997002295
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080238
• 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: 2406
• Device Catalogue Number: 2406
• Device Lot Number: 16N08
• 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: 06/26/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1