MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number AZURION 7 M20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the a cable hose fell along with metal parts that were fixed to the cable hanger.The device was in clinical use.No patient/user harm reported.Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, there was a delay in diagnosis when the issue was identified but no harm to the patient or user has been reported.The philips field service engineer (fse) inspected the system onsite and confirmed that cable hose fell along with metal parts that were fixed to the cable hanger.The operator moved a monitor ceiling suspension during an examination and monitor ceiling suspension was not moving as expected.As a part of troubleshooting process, the onsite engineer removed the bolts and nuts from the metal fittings mounting part, applied a screw loosening prevention agent to the screw part, and reinstalled it.Similar measures were taken for the remaining bellows mounting brackets.In addition, the tightness of the screws around the bellows and the monitor was checked and readjusted.The field service engineer stated that the reported problem was caused by structural issues with the fixture.Instead of a nut from the top, it must be secured so that it cannot be fundamentally pulled out.The periodic checks for looseness were performed, and the fse replaced the cable carrier with a hose carrier.After which, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.This scenario refers to the hoses and cables that are securely attached to the azurion system and are suspended from the ceiling away from the bed.As per the ifu warnings and in line with standard clinical workflow practices, the users, operators, and personnel should always be aware of potential collisions or inadvertent contact with other machines or devices in the operating room or catheterization lab.However, there may be instances when a person has accidentally hit their head on a hose.Should this occur, it is not likely to result in a serious injury/death.Given these considerations, it is unlikely that low hanging cables or hoses would cause a hazardous situation that may lead to serious injury or death, therefore this event is not considered to be reportable.Given these considerations, this scenario is not likely to cause/contribute to serious injury or death should it recur.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.Health impact code was corrected.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16160927
• MDR Text Key: 307321088
• Report Number: 3003768277-2023-00313
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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