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

Model Number 722026

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Philips has received through the food and drug administration medwatch program a voluntary event report submitted by orlando regional medical center (report number (b)(4)).In this report, it was reported: ¿i was assisting with removing patches from the patient¿s back.I was on the right side of the table.I rolled the patient on his side and while i was rolling him, his knee and the mattress leaned on the mushroom releasing the table.The patient slid off the table with the mattress on his side toward me.I held the patient on his side while sliding so that he did not harm any part of his body and supported his head till we stopped moving.I stayed with the patient supporting him until the staff came to assist me in lying him flat on the floor.We transferred him onto a sheet, then 5 staff members helped lift him onto the stretcher.The patient was assessed by the nurses and dr., no injuries were found, and the patient stated that he had no complaints of pain or distress.The staff hooked up vitals and monitored the patient until he was transferred to post unit.¿ the event was reported by the customer as a product problem.In the event description, it was indicated ¿no injuries were found, and the patient stated that he had no complaints of pain or distress¿.Based on this information, philips considers this a non-adverse event.Philips has initiated an investigation of this complaint.

Event Description

Philips has received through the food and drug administration medwatch program a voluntary event report submitted by (b)(6) regional medical center (report number (b)(4)).In this report, it was reported: ¿i was assisting with removing patches from the patient¿s back.I was on the right side of the table.I rolled the patient on his side and while i was rolling him, his knee and the mattress leaned on the mushroom releasing the table.The patient slid off the table with the mattress on his side toward me.I held the patient on his side while sliding so that he did not harm any part of his body and supported his head till we stopped moving.I stayed with the patient supporting him until the staff came to assist me in lying him flat on the floor.We transferred him onto a sheet, then 5 staff members helped lift him onto the stretcher.The patient was assessed by the nurses and dr., no injuries were found, and the patient stated that he had no complaints of pain or distress.The staff hooked up vitals and monitored the patient until he was transferred to post unit.¿ the event was reported by the customer as a product problem.In the event description, it was indicated ¿no injuries were found, and the patient stated that he had no complaints of pain or distress¿.Based on this information, philips considers this a non-adverse event.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Final report: philips investigated this complaint.Philips checked the system on site and no malfunction of the system was identified.The customer confirmed that its staff was not following proper protocol when lifting and moving the patient from the stretcher to/from the table.The staff has been re-educated on proper lifting and moving of patients.No further actions will be taken by philips 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
• 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: 9166280
• MDR Text Key: 175738562
• Report Number: 3003768277-2019-00079
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K031333
• 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: 09/10/2019

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: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR