MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD20

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

Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/24/2022

Event Type  Injury  

Event Description

It has been reported to philips that a patient fell from the ad7 table after cpr and rosc (return of spontaneous circulation) was established.The patient was undergoing a pacemaker procedure and the pocket was already created when the patient fall occurred.The patient¿s pacemaker pocket became contaminated and the procedure was aborted.The pocket was cleaned, antibiotics were administered and the patient had to stay overnight in the icu.The following day, the pacemaker procedure was completed and the patient was discharged home with post discharge follow up for infection control.Philips has started an investigation of this complaint.

Manufacturer Narrative

According to information obtained from the customer, the patient coded during the procedure and received cpr while on the table.After rosc, the patient fell from the table.The customer alleged that the issue was caused by the narrow tabletop of the ad7 patient support.The patient's health history and medical conditions included complete heart block, diabetes mellitus type 2, hypertension, morbid obesity, and osteomyelitis.The patient stayed the night in the icu, and antibiotics and infection control were required.The procedure was repeated the day after the initial treatment attempt occurred, and the patient was discharged the following day after being monitored for infection by an infection control team.Philips investigated the reported event.There was no malfunction of the system.The tabletop is designed to maintain free & efficient geometry movement around the patient, including lateral and longitudinal positioning of regions of interest, x-ray (absorption, attenuation & scatter) and patient comfort to enable interventional imaging for various clinical procedures.Additionally, the table is slim because it allows an ergonomic positioning of the operator.By having a slim table, the operator can stand very close to the patient and reduce the need to bend the body of the operator during interventions.Philips offers a wide range of accessories for patient positioning on the table.Straps can be used to secure the patient on the table during interventions.Elbow supports are designed to support the patient¿s elbows and arms in order to place the arms comfortably during examinations and also prevent the patient's arms from hanging over the side of the table.Shoulder support boards can be used to support both the arms of the patient during procedures; they are placed between the mattress and the tabletop and are kept in place by patient¿s weight.It was confirmed that straps were not used by the customer during the procedure in the catheterization lab.Corrected data: codes are updated as per the investigation outcome.

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 15071573
• MDR Text Key: 296287460
• Report Number: 3003768277-2022-00342
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2008
• 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; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 198 KG