MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX850 PATIENT MONITOR

Model Number	866470
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that their device was having a speaker malfunction.The device was in use when the issue was discovered but no patient harm occurred.
Event or Problem Description
Philips received a complaint on the intellivue mx850 indicating that the device had speaker malfunction issues.A good faith effort was completed to obtain additional details regarding the device allegation.The gfe response confirmed that the device displayed a speaker inop, but produced sound.No adverse event occurred.A philips field service engineer (fse) went to the customer site.The fse evaluated the intellivue mx850, but was unable to reproduce the speaker inop.As the issue was said to be intermittent per the customer, the fse recommended replacement of the device speaker.The fse is awaiting approval from the customer to replace the speaker.Results of functional testing indicate the device speaker functions normally.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The device was functioning according to specification at the time that it was evaluated, but since the speaker failure inop was intermittent per the customer, the fse recommended replacement of the speaker.The customer has yet to authorize replacement of the speaker.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX850 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX850 PATIENT MONITOR
• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 16397829
• Report Number: 9610816-2023-00086
• Device Sequence Number: 20426866
• Product Code: MHX
• UDI-Device Identifier: 00884838070790
• UDI-Public: 00884838070790
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K210906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 866470
• Device Catalogue Number: 866470
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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