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

Model Number 865241

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

The customer reported that the invasive blood pressure (ibp) alarms reset themselves to "off" on the intellivue mx700 patient monitor despite being enabled in the settings.It is unknown if the device was in use monitoring a patient at the time of the reported issue.No adverse patient event was reported.

Manufacturer Narrative

Philips received a complaint on the intellivue mx700 patient monitor indicating that the invasive blood pressure (ibp) alarms were automatically reset to off-alarm status, despite being enabled in the settings.The following functional tests were performed: a field service engineer (fse) went onsite and was unable to observe any problem.The fse retrieved the monitor logs and found no anomalies.The fse also carried out alarm testing, but everything was working correctly.It was requested that the customer provide a specific example of the problem (time, patient, etc.) from the medical staff in order to better analyze it.The customer will contact philips if the problem arises again in order to recover the logs on the control unit.The customer has already requested training for the staff.Based on the information available and the testing conducted, the fse was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The device remains at the customer site.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: 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 ; 7031463203
• MDR Report Key: 18180661
• MDR Text Key: 328621579
• Report Number: 9610816-2023-00610
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1