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

Model Number	865241
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 20oct2023, additional information was received indicating that this report, with the event date of (b)(6) 2023, was created for additional investigation of an event that occurred on (b)(6) 2023 (addressed in mfr report number 1218950-2023-00620); no root cause could be determined at that time, and the customer did not request further investigation at that time, but did so later on (b)(6) 2023.Allegation against the mx700 was indicated on (b)(6) 2023.See mfr report number 1218950-2023-00660 for the allegation against the philips patient information center ix.The following functional tests and communication were performed: a philips field service engineer (fse) and a clinical specialist (cs) went to the customer site to evaluate the device and to determine a root cause of the customer's allegation that "on (b)(6) 2023 at 8:57am patient assigned to bed 3411 in nicu department had a heart rate (hr) of 310 bpm but no alarm from piic ix computer was displayed.Hr high limit was set to 200." the fse and cs reviewed audit logs from (b)(6) 2023 and tested the device to ensure the mx700 monitor was alarming appropriately.The fse stated that looking at the audit logs across multiple days, the baby alarmed consistently, then there was about an hour gap during the event where the baby did not alarm at all during the time frame in question.The baby had and has continued to alarm without issue.This was also validated on-site using a chicken heart to generate multiple alarms at all different limits, using the monitor in question.The fse and cs believed this anomaly is due to something customer related and not the monitor.Results of functional testing and log review determined the mx700 monitor was alarming per specifications and the event may have been an anomaly not related to the device, but more likely user error.The engineer provided their analysis findings.The lack of alarm occurred was considered an anomaly not related to the device, but the root cause is unknown.Extensive tests were performed and the device was confirmed to be operating per specifications.There was no patient harm.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported the patient¿s heart rate exceeded the high limit, but no alarm generated on the philips patient information center ix (pic ix) computers in neonatal intensive care unit (nicu) department.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
D4 unique device identifier (udi) was corrected.

• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17994778
• Report Number: 9610816-2023-00543
• Device Sequence Number: 20552235
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088(21)DE58543493
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 865241
• Device Catalogue Number: 865241
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• 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