MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE SENSOR; OXIMETER

Model Number	2479
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts for the return of the product as well as additional information requests have been made in order to identify the product involved in the reported event.The customer indicated that the product used for this event was discarded and the lot/serial number was not available.If new information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported by masimo clinical specialist: "at some point during the cardiac surgery, the patient started to sweat massively, vegetatively.The sedline sensor all of a sudden couldn¿t get a proper eeg reading anymore, the sensor¿s electrodes said to have high impedance on the root monitor for a very short time and then continued to be green on the monitor which means the sensor has normal impedance and gets eeg data.Nevertheless, the monitor showed a high number of artifacts, at a 100%.Together with the anesthetist we could exclude external reasons for having those artifacts like electrocautery or manipulation close to the sensor itself.Then, i disconnected the sedline sensor from the patient cable and could see it was severely wet from the patient sweating extremely.We dried the connection and reconnected it, by then the eeg reading was ok again and we could see the dsa also.Now, we could see external interferences in the dsa that showed up all of a sudden.Since the setting in the or has not changed and the root monitor was on the same place than before and even grounded we could not see the source of interferences.By looking at the impedance all the time it was ¿green¿, so it seemed to be fine.Still, the measurement was not as stable as before." no consequences or impact to patient was reported.

• Brand Name: SEDLINE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7045810
• Report Number: 2031172-2017-01028
• Device Sequence Number: 10802041
• Product Code: MWI
• UDI-Device Identifier: 10843997005804
• UDI-Public: 10843997005804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

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: 03/01/2020
• Device Model Number: 2479
• Device Catalogue Number: 2479
• Device Lot Number: 17F1L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1