MAUDE Adverse Event Report: PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA WITH FLAT; SYSTEM, X-RAY, STATIONARY

Model Number 708034

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

Patient Problem Concussion (2192)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a report that a user suffered from a concussion and was signed off for work for two weeks.The user bent down to pick some items on the floor, she was underneath the monitor assembly and when she returned to the standing position, she banged her head with the rail of the monitor assembly.

Manufacturer Narrative

Philips investigated this complaint.Philips checked the system on site three out of the five gas springs that hold the suspension monitor were defective.This resulted in the monitor not holding the position where it was moved.The gas springs were replaced and the system was returned in good working order.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: MULTIDIAGNOST ELEVA WITH FLAT
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8486629
• MDR Text Key: 141029482
• Report Number: 3003768277-2019-00028
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K961374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: 708034
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other