MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number	865241
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
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.(b)(6).G5: 510k is unknown at the time of the report.D1, d2, and d4: product information is unknown at the time of the report.
Event or Problem Description
Customer reported the desat alarms did not sound.Patient involvement is unknown.There was no report of patient or user harm.
Event or Problem Description
The customer reported the desaturation alarms do not sound.Customer wanted to change the configuration.Patient involvement is unknown.There was no report of patient or user harm.
Additional Manufacturer Narrative
The customer spoke with the remote service engineer(rse).It was noted the issue was only present during use.The issue could not be confirmed on the simulator.Customer requested a procedure to adjust the alarm frequency and volume configuration.Rse provided.G5: good faith efforts have been completed to request product information but the information is still unknown.Based upon gfe response, it is believed the customer was referring to their mx700 device, however, this is an educated belief.To avoid having no model number in the emdr follow up report, mx700 will be used.If additional information regarding the product used is received, the complaint will be reopened and a supplemental report sent.H3 other text : customer refused.
Additional Manufacturer Narrative
D4: udi is unknown as serial number was not provided for this complaint.If information is provided a supplemental report will be sent.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX700 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: 18255902
• Report Number: 9610816-2023-00638
• Device Sequence Number: 6685816
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150310
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 07/08/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/17/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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