MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10 C; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722001

Device Problem Unintended Movement (3026)

Patient Problems Bruise/Contusion (1754); Fall (1848); Hematoma (1884); Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will be sent to the fda.

Event Description

It has been reported to philips that during lateral transfer of the patient from the bed to the table, the table pivoted causing the patient to fall to the floor.The patient sustained a skin tear and bruises.A ct scan confirmed that there was no fracture, only a hematoma.The procedure was aborted to apply wound care.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed with the customer that the patient was treated with bandages, dressings and a suture on the right leg.The patient has the pre-existing condition of fragile skin.Philips has inspected the system on site and confirmed that the push/pull gauge readings (of the force needed to push the table in the pivot axis) were within specifications.Further, philips confirmed that no parts in the table mechanism were defective.Philips has checked the service history of the system.Reports of the planned maintenance of the ad5 table that occurred prior to the incident ((b)(6) 2019) show that all tests passed and the system was working as designed and within specifications.The system was checked, calibrated and returned to use in good working order.No malfunction of the table could be identified.Philips has confirmed with the customer that the patient was transferred according to the instructions for use.The philips ad5 table is designed to stay in place by means of a table pivot, but also move when sufficient force is applied, so as not to injure hospital staff trying to move the table.The ad5 table has an optional accessory pivot lock which would further help keeping the table in place.However, the customer did not have a pivot lock installed with this table.The most likely cause of the incident is that in the absence of the pivot lock, the force required to move the table was exceeded during the patient transfer, causing the table to make an unintended movement.The pivot brake assembly and the friction pad, both parts of the table pivot, were replaced proactively in absence of a root cause.No similar complaints have been identified.Based on the investigation results, philips has concluded that there was no malfunction of the system.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10 C
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 10113644
• MDR Text Key: 194323094
• Report Number: 3003768277-2020-00030
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 105