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

Model Number 708034

Device Problem Mechanical Problem (1384)

Patient Problems Fall (1848); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Defective part has been send for investigation to manufacturer.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint in which it was reported that the operator was positioning the patient in the trendelenburg position.At some point the system didn't stop moving and it went over 90 degrees.The patient fell of the table, this resulted in a minor injury.

Manufacturer Narrative

The investigation conducted by philips concluded that the actuator failed due to loading fatigue of the actuator.Misalignment of the actuator points or hitting an obstacle during table movement contribute to this loading fatigue.The defective parts were replaced and the system is in use now.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7028242
• MDR Text Key: 92504986
• Report Number: 3003768277-2017-00094
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K961374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 708034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2007
• 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 Age: 66 YR
• Patient Weight: 87