MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AD7 TABLE WITH ALLURA XPER; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number AD7 000019

Device Problem Unintended Movement (3026)

Patient Problems Laceration(s) (1946); Paresis (1998)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Patient was intubated and being transferred for extubation on a cart.All four individuals in the room were assisting with a board exam table to cart transfer.While rolling the patient towards myself, the table mattress began to shift with the patient and she began to fall on me.I braced my body up against hers and braced my hip to the exam table and tried to use my body to keep her on the table.Her head and shoulders continued to fall off the table to my left.As she continued to fall, i wrapped both my arms around her legs to stop the fall.At this point, 2 others were also trying to grab onto her.She continued to fall head and shoulders over hips onto the floor.Traumatic extubation, laceration to head requiring sutures, she does have a new right vocal cord paresis.This could be related to her traumatic extubation/re-intubation, or potentially related to her recent sclerotherapy in the region of the recurrent laryngeal nerve.Mattress was attached on two areas with velcro.

• Brand Name: AD7 TABLE WITH ALLURA XPER
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; 3721 valley centre drive, suite 500; san diego CA 92130
• MDR Report Key: 14266038
• MDR Text Key: 290545141
• Report Number: 14266038
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: AD7 000019
• Device Catalogue Number: AD7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization