MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP50; BEDSIDE PATIENT MONITOR

Model Number 862116

Device Problem Device Fell (4014)

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

The philips field service engineer (fse) report the issue on the customer's behalf.It was reported that the mp50 fell.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.The fse confirmed that the display and main unit frame were damaged because the mp50 was dropped.The fse repaired the part, inspected it, and carried out a heat run, and confirmed normal operation.

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.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer's site to evaluate the device in question.The fse confirmed the mp50 was dropped during transport unmounted to any fixture.The staff put the mp50 directly on the bed resulting in its fall causing display and main unit frame damage.The fse repaired the unit, conducted a heat run, and inspected it thoroughly.The unit passed performance verification testing and returned to normal operation.The device remains in use at the customer's site.

• Brand Name: INTELLIVUE MP50
• Type of Device: BEDSIDE 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: 17862647
• MDR Text Key: 325812832
• Report Number: 9610816-2023-00498
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151681
• 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: 862116
• Device Catalogue Number: 862116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2007
• 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