MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH MASIMO SEDLINE MODULE

Model Number	867186
Medical Device Problem Codes	Increase in Pressure (1491); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.Reporting institution name: (b)(6).Reporting address state: (b)(6).
Event or Problem Description
The sedline device is a depth of anaesthesia monitor.It analyses the eeg of the anaesthetised patient.This analysis is displayed as a psi number.The range 25-50 is suggested to show adequate surgical anaesthesia.The raw eeg is also displayed, as is the sef - spectral edge frequency - another indicator of adequate anaesthesia.The use of depth of anaesthesia devices is recommended with total intravenous anaesthesia to prevent awareness during surgery.They are also considered useful to prevent overdosage of anaesthetic agents, and thus minimise the chance of post operative cognitive dysfunction.The psi displayed by sedline is proving unreliable.The number spontaneously climbs, suggesting inadequate anaesthesia, whilst all other clinical signs remain normal.
Additional Manufacturer Narrative
A philips remote service engineer (rse) attempted to reach out to the customer and received no response.It is unknown if the device was evaluated or what caused the issue.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.It is unknown if the device is back in service due to insufficient information.The customer did not call back or email back for further support.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.No response from customer.
Additional Manufacturer Narrative
H6 device problem code was corrected.

• Brand Name: MASIMO SEDLINE MODULE
• Common Device Name: MASIMO SEDLINE MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16885220
• Report Number: 9610816-2023-00215
• Device Sequence Number: 6163358
• Product Code: OLW
• UDI-Device Identifier: 00884838051515
• UDI-Public: 00884838051515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 867186
• Device Catalogue Number: 867186
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 07/27/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/14/2023; 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown