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

Model Number AZURION 7 M20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/04/2023

Event Type  Injury  

Event Description

It has been reported to philips that the patient fell off table during a bi-ventricular implantable cardioverter defibrillator (icd) implant to the left chest procedure.The patient was under anesthesia and intubation and became restless with legs moving.The patient fell from the table, with upper body hitting/landing on c-arm and the legs remaining secured on the table.The patient's chest was imaged, and the pacer pocket sutured closed.The procedure was aborted and the patient transferred to intensive care unit (icu).Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated the complaint.According to the information provided, the customer was performing a planned non-emergency procedure, during which third party safety straps were used to strap the patient.After the patient fell, the patient had bruising and rib pain and was admitted to the hospital, however diagnostic images showed no internal injuries.The customer reported that the patient had morbid obesity and that the patients' habitus and overall body composition may have had a significant contribution to the incident.Patient information has been updated.

• 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: 16223640
• MDR Text Key: 307890224
• Report Number: 3003768277-2023-00441
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163715
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 02/23/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 136 KG