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

Model Number 865241

Device Problem Device Fell (4014)

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

Event Date 06/05/2023

Event Type  malfunction  

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 Description

The customer reported the mx700 has fallen off a wall and onto a neonatal cot.The monitor was removed from use due to clinical risk.The device was not directly in use as the patient was not in the cot at the time of the incident.No adverse event to the patient or user was reported.

Manufacturer Narrative

A philips account manager (ac) remotely interviewed the customer who was onsite.The mounting arm was confirmed to be a gcx vhm mount which was mounted on a stud wall.The ac confirmed philips initially installed the mount; however, the customer moved the mount during a ward expansion.There was no philips field service engineer (fse) onsite for physical inspection thus far.However, technical contractors were sent to complete a load test report.The customer confirmed the mounting arm could be adjusted to increase tension.At the time of the event, there was nothing happening that would cause the mounting arm to fall.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be user error.The customer moved the mount during a ward expansion.The customer plans to relocate the mounting arms to a more secure wall mount, so that they are not located directly above the cot spaces.The device remains at the customer site.The instructions for use (ifu) states "mount the monitor using either the philips quick mount or fix mount solution or another approved mounting solution.Select the mounting equipment and the mounting position so that no patient, operator or other person can be harmed by a monitor removed intentionally or released accidentally from the mount.When using the quick mount, be aware of the danger of accidental activation of the quick mount release button when lifting or moving items located under the monitor, such as pole mounts, etc.If in doubt, use the philips fix mount solution to avoid such situations.Refer to the respective intellivue monitor service manual, installation instructions chapter, for more details.

• 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: 17219431
• MDR Text Key: 318037661
• Report Number: 9610816-2023-00315
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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