MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER SLCP

Model Number	866462
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the neo spo2 disposable sensor failure can't measure after an hour.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).
Additional Manufacturer Narrative
Upon further investigation it was found that the event is not a reportable event for philips.The customer stated that there was no reading.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The failure to perform measurements would generate an inop message and alarm tone that would alert users to a problem and appropriate actions would be taken per hospital protocol to resolve the situation.As per the definition of non-reportable, this device/product issue did not cause or contribute to death or serious injury nor would likely cause or contribute to death or serious injury upon recurrence.The record was reviewed and evaluated to pose no health or safety risk to patients, users, or bystanders.No death, serious injury or adverse event was reported to have occurred or was alleged as a result of this issue, nor is this issue likely to cause or contribute to such an event if it were to recur.
Event or Problem Description
The customer reported reported that the neo spo2 disposable sensor failure after 1 hour of measurement.The device was used for patient monitoring at the time of the alleged malfunction, there was no adverse event reported.A philips field service engineer (fse) went to the customer site.The engineer determined that the issues was associated with the neo spo2 disposable sensor.After replacement the spo2 sensor was returned to functional use with no further issue(s) identified.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• 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: 16066621
• Report Number: 9610816-2022-00659
• Device Sequence Number: 6733325
• Product Code: MHX
• UDI-Device Identifier: 00884838055094
• UDI-Public: 00884838055094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• 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: 866462
• Device Catalogue Number: 866462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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