MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MULTIDIAGNOST ELEVA; SYSTEM, X-RAY, STATIONARY

Model Number MULTIDIAGNOST ELEVA

Device Problem Smoking (1585)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the valera e-cabinet converter electrically burned up causing smoke and smell.This led to the evacuation of the building's patients and employees.The system was not in clinical use.No harm has been reported however, people complained about smoke and smell irritation.Philips has started an investigation of this complaint.

Manufacturer Narrative

A philips service engineer inspected the system onsite and confirmed the reported issue.Investigation of the converter 8e velara showed that the electrical mains input wires burned causing a short circuit.The converter was replaced and the system was returned to use in good working order.The defective converter was returned and analyzed.The analysis confirmed a short circuit in the capacitors on the printed circuit board assembly (pbca).Corrected data: codes are updated as per the investigation outcome.

• Brand Name: MULTIDIAGNOST ELEVA
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15367930
• MDR Text Key: 299359389
• Report Number: 3003768277-2022-00408
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• 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: MULTIDIAGNOST ELEVA
• Device Catalogue Number: 708038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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