MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number	866060
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient involvement was reported.Information received indicated the patient's oxygen saturation did recover but any intervention required remained unknown.Response to good faith effort (gfe) stated no injuries.Additional information including clinical audit logs/ technical logs, (start date logs including the rfda(radio frequency data acquisition) and device debug logs were requested, but the customer is not willing to provide any further details.Additional information was requested, but the customer did not provide any further details.Due to the lack of information a technical investigation could not be performed and the cause of the reported issue remains unknown.Reporter and reporting institution phone # (b)(6).
Event or Problem Description
It was reported the monitor did not generate a desaturation alarm.For this newborn patient hospitalized for vomiting, the spo2 measurement parameters were set with a low of 90%; however, when the measurement indicated 84%, there was no alarm.Additional information received from the customer regarding patient harm and medical intervention was contradictory in nature to the original complaint.It was indicated no medical intervention was necessary, yet the patient's oxygen saturation did not recover spontaneously.In addition, it was indicated the alleged issue affected the patient condition, yet new information indicates no injury.The customer also indicated they did not remember if alarms were generated or not; however, no device logs were provided per philips request.Biomedical engineering performed a monitor restart and there were no functional issues noted.Based on this information, it remains unclear if alarms were generated or whether there was actual harm to the patient.The customer did not provide additional information.Though it remains unknown whether oxygen desaturation recovered spontaneously or required intervention, the response from the customer indicates there was no harm to the patient due to the reported alarm issue.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX400 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: 20672877
• Report Number: 9610816-2024-00806
• Device Sequence Number: 7285842
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: (01)00884838038752
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130849
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: 866060
• Device Catalogue Number: 866060
• 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: 10/16/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2017
• 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