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 09/27/2023

Event Type  malfunction  

Event Description

The customer reported that the device fell due to the mounting issue.It is unknown if the device was in use at time of event, and there was no adverse event reported.

Manufacturer Narrative

The remote service engineer (rse) spoke with the customer and determined that the device attached to an arm and by wear and tear the fastening system did not hold anymore, the monitor fell.The customer advised that the device was pushed into the support pin but does not clip anymore.The rse determined that the fastening system and screen required replacement.The customer was provided a replacement quick mount and display to resolve the issue.

• 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: 17922954
• MDR Text Key: 326062121
• Report Number: 9610816-2023-00519
• 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

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: 09/27/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2013
• 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